{"id":"telisotuzumab","rwe":[{"pmid":"41910595","year":"2026","title":"Telisotuzumab Adizutecan (ABBV-400), a Novel c-Met-Targeting Antibody-Drug Conjugate: First-in-Human Results in Advanced Gastric/Gastroesophageal Junction Cancer.","finding":"","journal":"Clinical cancer research : an official journal of the American Association for Cancer Research","studyType":"Clinical Study"},{"pmid":"41754785","year":"2026","title":"2025 FDA TIDES (Peptides and Oligonucleotides) Harvest.","finding":"","journal":"Pharmaceuticals (Basel, Switzerland)","studyType":"Clinical Study"},{"pmid":"41748495","year":"2026","title":"Population Pharmacokinetics and Exposure-Response Analyses for Telisotuzumab Vedotin in Patients With c-Met Protein Overexpressing Tumors.","finding":"","journal":"CPT: pharmacometrics & systems pharmacology","studyType":"Clinical Study"},{"pmid":"41595127","year":"2026","title":"Targeting Mesenchymal-Epidermal Transition (MET) Aberrations in Non-Small Cell Lung Cancer: Current Challenges and Therapeutic Advances.","finding":"","journal":"Cancers","studyType":"Clinical Study"},{"pmid":"41460676","year":"2026","title":"Emrelis: A New Approach in Treating MET-high Locally Advanced or Metastatic Non-squamous NSCLC; A Mini Review.","finding":"","journal":"Thoracic research and practice","studyType":"Clinical Study"}],"_fda":{"id":"998985bb-7cd1-4e80-bd08-8fc7c503f982","set_id":"bc04f980-3957-4e35-ab81-8ec2ffe87215","openfda":{"unii":["976X9VXC3Z"],"route":["INTRAVENOUS"],"rxcui":["2714245","2714251","2714253","2714255"],"spl_id":["998985bb-7cd1-4e80-bd08-8fc7c503f982"],"brand_name":["EMRELIS"],"spl_set_id":["bc04f980-3957-4e35-ab81-8ec2ffe87215"],"package_ndc":["0074-1044-01","0074-1055-01"],"product_ndc":["0074-1044","0074-1055"],"generic_name":["TELISOTUZUMAB VEDOTIN"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["TELISOTUZUMAB VEDOTIN"],"manufacturer_name":["AbbVie Inc."],"application_number":["BLA761384"],"is_original_packager":[true]},"version":"3","pregnancy":["8.1 Pregnancy Risk Summary Based on the mechanism of action and findings in animals, EMRELIS can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available human data on EMRELIS use in pregnant women to inform a drug-associated risk. In an animal reproduction study, administration of the small molecule component of EMRELIS, MMAE, to pregnant rats during organogenesis resulted in embryo-fetal mortality and structural abnormalities at exposures similar to the clinical exposure at the recommended dose [see Data ] . Advise patients of the potential risks to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data No embryo-fetal development studies in animals have been performed with telisotuzumab vedotin-tllv. In an embryo-fetal development study in pregnant rats, administration of two intravenous doses of MMAE, the small molecule component of EMRELIS, on gestational days 6 and 13 caused embryo-fetal mortality and structural abnormalities, including protruding tongue, agnathia, malrotated limbs, and gastroschisis compared to controls at a dose of 0.2 mg/kg (approximately 2 times the human area under the curve [AUC] at the recommended dose)."],"references":["15 REFERENCES 1. \"OSHA Hazardous Drugs.\" OSHA . http://www.osha.gov/SLTC/hazardousdrugs/index.html"],"description":["11 DESCRIPTION Telisotuzumab vedotin-tllv is a c-Met directed antibody-drug conjugate (ADC) comprised of a humanized immunoglobulin G1 kappa (IgG1κ) monoclonal antibody conjugated to the small molecule microtubule-disrupting agent, monomethyl auristatin E (MMAE), via a protease-cleavable valine-citrulline (vc) linker. The antibody is produced in a mammalian cell line (Chinese hamster ovary) and the drug-linker is produced by chemical synthesis. Each monoclonal antibody molecule carries an average of 3 MMAE molecules. Telisotuzumab vedotin-tllv has an approximate molecular weight of 152 kDa. EMRELIS (telisotuzumab vedotin-tllv) for injection is a sterile, white to off-white, preservative-free, lyophilized powder in a single-dose vial for reconstitution and dilution prior to intravenous infusion. EMRELIS is supplied as 20 mg per vial or 100 mg per vial and requires reconstitution with Sterile Water for Injection, USP (1.1 mL and 5.2 mL, respectively) to obtain a concentration of 20 mg/mL [see Dosage and Administration ( 2.4 )] . Following reconstitution, each mL delivers 20 mg of telisotuzumab vedotin-tllv, and histidine (2.33 mg), polysorbate 80 (0.10 mg), sucrose (70.0 mg), and Water for Injection. Hydrochloric acid was added to adjust the pH to 6.0. Telisotuzumab vedotin-tllv is a c-Met directed antibody-drug conjugate (ADC) comprised of a humanized immunoglobulin G1 kappa (IgG1κ) monoclonal antibody conjugated to the small molecule microtubule-disrupting agent, monomethyl auristatin E (MMAE), via a protease-cleavable valine-citrulline (vc) linker. The antibody is produced in a mammalian cell line (Chinese hamster ovary) and the drug-linker is produced by chemical synthesis. Each monoclonal antibody molecule carries an average of 3 MMAE molecules. Telisotuzumab vedotin-tllv has an approximate molecular weight of 152 kDa."],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied EMRELIS (telisotuzumab vedotin-tllv) for injection is a sterile, preservative-free, white to off-white lyophilized powder, supplied in a glass single-dose vial. Carton of one 20 mg/vial (NDC 0074-1044-01) Carton of one 100 mg/vial (NDC 0074-1055-01) Storage and Handling Store refrigerated at 2 o C to 8 o C (36 o F to 46 o F) in original carton to protect from light. Do not freeze. Do not shake. Special Handling EMRELIS is a hazardous product. Follow special handling and disposal procedures. 1"],"spl_medguide":["MEDICATION GUIDE EMRELIS™ (EM-rell-is) (telisotuzumab vedotin-tllv) for injection, for intravenous use What is the most important information I should know about EMRELIS? EMRELIS can cause serious side effects, including: Nerve problems in your hands or feet (peripheral neuropathy). Nerve problems are common during treatment with EMRELIS and can also be severe. Tell your healthcare provider if you develop any new or worsening signs or symptoms of nerve problems, including: numbness tingling burning sensation pain or discomfort muscle weakness difficulty walking Lung problems. EMRELIS can cause lung problems that may be severe, life-threatening or that may lead to death. Tell your healthcare provider right away if you develop new or worsening lung symptoms, including: cough trouble breathing or shortness of breath fever wheezing Eye problems. Your healthcare provider may send you to an eye care professional to check your eyes if you develop eye problems. Tell your healthcare provider right away if you develop any new or worsening eye problems or vision changes, including: blurred vision dry eyes sensitivity to light eye pain or swelling eye redness Infusion-related reactions. EMRELIS can cause infusion reactions that can be severe or life-threatening. Tell your healthcare provider right away if you develop any signs and symptoms of infusion reactions, including: itching or rash shortness of breath or wheezing flushing chest discomfort fever back pain chills headache nausea or vomiting feel like passing out Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with EMRELIS and may provide treatment for your side effects. Your healthcare provider may also need to change your dose, temporarily stop, or completely stop treatment with EMRELIS if you have severe side effects. See “What are the possible side effects of EMRELIS?” for more information about side effects. What is EMRELIS? EMRELIS is a prescription medicine used to treat adults with non-squamous non-small cell lung cancer (NSCLC): that has spread to areas near the lungs (locally advanced) or to other parts of the body (metastatic), and whose tumors have high c-Met protein overexpression, and who have received a prior treatment. Your healthcare provider will perform a test to make sure EMRELIS is right for you. It is not known if EMRELIS is safe and effective in children. Before receiving EMRELIS, tell your healthcare provider about all of your medical conditions, including if you: have a history of nerve problems have lung or breathing problems other than your lung cancer have eye problems have liver problems are pregnant or plan to become pregnant. EMRELIS can harm your unborn baby. Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with EMRELIS. You should use effective birth control (contraception) during treatment and for 2 months after your last dose of EMRELIS. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EMRELIS. Males with female partners who are able to become pregnant: You should use an effective birth control during treatment and for 4 months after your last dose of EMRELIS. are breastfeeding or plan to breastfeed. It is not known if EMRELIS passes into your breast milk. Do not breastfeed during treatment with EMRELIS and for 1 month after the last dose. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking certain medicines with EMRELIS may increase your risk of side effects. How will I receive EMRELIS? Your healthcare provider will give you EMRELIS into your vein through an intravenous (IV) line over 30 minutes. EMRELIS is given 1 time every 2 weeks. Your healthcare provider will decide how many infusions of EMRELIS you will receive. What are the possible side effects of EMRELIS? EMRELIS can cause serious side effects, including: See “What is the most important information I should know about EMRELIS?” The most common side effects of EMRELIS include: feeling tired swelling in the feet, ankles, legs or hands decreased appetite The most common severe abnormal laboratory test results with EMRELIS include: decreased white blood cell counts increased blood sugar levels increased blood liver enzyme levels decreased blood phosphorus levels decreased blood sodium levels decreased red blood cell counts decreased blood calcium levels EMRELIS may cause fertility problems in females and males, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility. These are not all the possible side effects of EMRELIS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. General information about the safe and effective use of EMRELIS. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about EMRELIS that is written for healthcare professionals. What are the ingredients in EMRELIS? Active ingredient: telisotuzumab vedotin-tllv Inactive ingredients: histidine, polysorbate 80, sucrose. Hydrochloric acid added to adjust the pH. Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA U.S. License Number: 1889 Marketed by: AbbVie Inc., North Chicago, IL 60064 U.S.A. ©2025 AbbVie. All rights reserved. EMRELIS and its design are trademarks of AbbVie Inc. For more information, go to www.EMRELIS.com or call 1-844-859-5760. This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 05/2025 20090524"],"geriatric_use":["8.5 Geriatric Use Of the 168 patients with previously treated EGFR wild-type non-squamous NSCLC with c-Met protein overexpression treated with EMRELIS in LUMINOSITY, 50% were ≥65 years of age and 12% were ≥75 years of age. No overall differences in safety or effectiveness were observed between older and younger patients."],"pediatric_use":["8.4 Pediatric Use Safety and effectiveness of EMRELIS have not been established in pediatric patients."],"effective_time":"20250525","clinical_studies":["14 CLINICAL STUDIES Previously Treated EGFR Wild-Type N on-squamous NSCLC with High c-Met Protein Overexpression LUMINOSITY The efficacy of EMRELIS was evaluated in the LUMINOSITY study (NCT03539536), a multicenter, open-label, single-arm, multi-cohort clinical trial. Eligible patients were required to have locally advanced or metastatic NSCLC with c-Met protein overexpression and treatment with prior systemic therapy (including no more than one line of prior chemotherapy) in the locally advanced or metastatic setting. The study excluded patients who had received radiation therapy to the lungs <6 months prior to enrollment and patients who had a history of ILD/pneumonitis requiring treatment with steroids or ILD/pneumonitis within 3 months of the first dose. Patients received EMRELIS at 1.9 mg/kg intravenously every 2 weeks until disease progression or unacceptable toxicity. The major efficacy outcome measure was overall response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by a blinded independent central review (BICR). An additional efficacy outcome measure was duration of response (DOR) by BICR. The efficacy population included 84 patients with non-squamous, EGFR wild-type NSCLC with high c-Met protein overexpression who had received prior systemic therapy. High c-Met protein overexpression was defined as ≥50% of tumor cells with strong (3+) membrane staining on archival or recent tissue samples by immunohistochemistry (IHC) and was determined by prospective testing at a central laboratory prior to enrollment using the MET (SP44) clinical trial assay (CTA). Of the 84 patients with high c-Met protein overexpression identified by central testing using the CTA, tissue samples from 38/84 (45%) patients were tested retrospectively using the VENTANA MET (SP44) RxDx assay. One sample was unevaluable. Of the 37 samples retested and evaluable, 32 (87%) samples were confirmed to have high c-Met protein overexpression, defined as ≥50% of tumor cells with strong (3+) membrane and/or cytoplasmic staining. The median age was 64 years (range: 38 to 83 years); 75% were male; 61% were White, 1.2% were Black or African American, 38% were Asian; none were of Hispanic or Latino ethnicity. Twenty-five percent had an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 and 74% had ECOG PS of 1; 19% were never smokers, 68% were former smokers, and 13% were current smokers; 99% had Stage IV disease; and 19% of patients had previously treated brain metastases. The median number of lines of prior therapies was 1 (range 1 - 3); 73% of patients had one line, 24% had two lines, and 3.6% had three lines of prior systemic therapy; 96% of patients had prior platinum therapy, 82% had prior immunotherapy (anti-PD-1/PD-L1), 6% had prior targeted therapy, and 3.6% had prior MET tyrosine kinase inhibitor therapy. Efficacy results are summarized in Table 8. Table 8. Efficacy Results in LUMINOSITY for Patients with EGFR Wild-Type Non-squamous NSCLC with High c-Met Protein Overexpression Efficacy Parameter EMRELIS N = 84 Confirmed Overall Response Rate (ORR) , % (95% CI) 35 (24, 46) Complete Response, % 0 Partial Response, % 35 Duration of Response N = 29 Median, months (95% CI) 7.2 (4.2, 12) DOR ≥6 months, a % 59 DOR ≥12 months, a % 21 CI=confidence interval; DOR=duration of response a Based on observed duration of response in 29 responders."],"pharmacodynamics":["12.2 Pharmacodynamics Exposure Response Relationships Exposure-response relationships for efficacy and time course of pharmacodynamic response have not been fully characterized. Higher telisotuzumab vedotin-tllv exposure was associated with increased rates of Grade 3 peripheral neuropathy, and Grades 2 and 3 ocular surface disorders. Higher unconjugated MMAE exposure was associated with increased rates of Grade ≥3 adverse reactions and fatal adverse reactions. Cardiac Electrophysiology There is insufficient information to characterize the effect of telisotuzumab vedotin-tllv on the QT interval."],"pharmacokinetics":["12.3 Pharmacokinetics The exposure parameters of telisotuzumab vedotin-tllv (ADC) and unconjugated MMAE (cytotoxic component of EMRELIS) are summarized in Table 7. The plasma exposure of the ADC and unconjugated MMAE increased proportionally over a dose range of 1.2 to 3.3 mg/kg (0.64 to 1.7 times the approved recommended dose). ADC time to maximum plasma concentrations (Tmax) occurs at the end of intravenous infusion while MMAE Tmax occurs approximately 5 days after EMRELIS administration. Minimal accumulation of the ADC or MMAE occurs. Table 7. Exposure Parameters of Telisotuzumab Vedotin-tllv (ADC) and Unconjugated MMAE at EMRELIS 1.9 mg/kg Every 2 Weeks ADC Unconjugated MMAE C max 29 (43) µg/mL 2.2 (53) ng/mL AUC 0- tau 2,130 (55) µg∙hr/mL 405 (64) ng∙hr/mL C max = maximum concentration AUC 0- tau = area under the concentration-time curve from time zero to 14 days (2 weeks) Distribution The estimated volume of distribution is 3.4 L (16.5%CV) for telisotuzumab vedotin-tllv. MMAE plasma protein binding ranges from 68% to 82% in vitro . Elimination The elimination half-life is approximately 3 days for the ADC and approximately 4 days for MMAE. The estimated clearance (CL) is 1.3 L/day (31.5%CV) for the ADC and 76 L/day (52.1%CV) for MMAE. Metabolism Telisotuzumab vedotin-tllv catabolism has not been studied in humans; however, it is expected to undergo catabolism to small peptides, amino acids, unconjugated MMAE, and unconjugated MMAE-related catabolites. MMAE is metabolized primarily by CYP3A4. Specific Populations No clinically significant differences in the pharmacokinetics of the ADC or unconjugated MMAE were observed based on age (30 to 87 years), sex, race (65% White, 32% Asian, and 3% Black), body weight (34 to 144 kg), mild or moderate renal impairment (CLcr 30 to 89 mL/min, estimated by Cockcroft-Gault), or mild hepatic impairment (total bilirubin ≤ULN and AST >ULN or total bilirubin >ULN and ≤1.5 x ULN and any AST). The effect of severe renal impairment (CLcr <30 mL/min), end-stage renal disease with or without dialysis, or moderate to severe hepatic impairment (total bilirubin >1.5 × ULN and any AST) on the pharmacokinetics of telisotuzumab vedotin-tllv or unconjugated MMAE is unknown. Drug Interaction Studies Clinical Studies and Model-Informed Approaches: No clinical studies have evaluated the potential for drug-drug interactions. Strong CYP3A4 Inhibitor: MMAE AUC is predicted to increase by 1.4-fold following concomitant administration of EMRELIS with ketoconazole (a strong CYP3A inhibitor). Strong CYP3A4 Inducer: MMAE AUC is predicted to decrease by 70% following concomitant administration of EMRELIS with rifampicin (a strong CYP3A inducer). Sensitive CYP3A Substrate: No clinically significant difference in the pharmacokinetics of midazolam (a sensitive CYP3A substrate) is predicted when used concomitantly with EMRELIS. In Vitro Studies Cytochrome P450 (CYP) Enzymes: MMAE is a substrate and an inhibitor of CYP3A4/5. Transporter Systems: MMAE is a substrate of P-glycoprotein (P-gp)."],"adverse_reactions":["6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Peripheral Neuropathy [see Warnings and Precautions ( 5.1 )] Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions ( 5.2 )] Ocular Surface Disorders [see Warnings and Precautions ( 5.3 )] Infusion-Related Reactions (IRR) [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (≥20%) were peripheral neuropathy, fatigue, decreased appetite, and peripheral edema. ( 6.1 ) The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocytes, increased glucose, increased alanine aminotransferase, increased gamma glutamyl transferase, decreased phosphorus, decreased sodium, decreased hemoglobin and decreased calcium. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. LUMINOSITY The safety population described in WARNINGS AND PRECAUTIONS and below reflects exposure to EMRELIS in 168 patients with locally advanced or metastatic EGFR wild-type non-squamous NSCLC with c-Met protein overexpression who received EMRELIS as a single agent administered at 1.9 mg/kg intravenously every 2 weeks in the LUMINOSITY study [see Clinical Studies ( 14 )]. Among patients who received EMRELIS, 42% were exposed for 6 months or longer and 11% were exposed for greater than one year. The median age of patients who received EMRELIS was 64.5 years (range: 33 to 83 years); 70% were male; 65% were White; 1.8% were Black or African American, 33% were Asian; and 0.6% were of Hispanic or Latino ethnicity. Serious adverse reactions occurred in 35% of patients. Serious adverse reactions occurring in ≥2% of patients included ILD/pneumonitis (5%), pneumonia (5%), peripheral neuropathy (3.6%), and pleural effusion (2.4%). Fatal adverse reactions occurred in 5% of patients who received EMRELIS, including ILD/pneumonitis (1.8%), pneumonia (1.2%), sudden death (1.2%), noninfectious endocarditis (0.6%) and myocardial infarction (0.6%). Permanent discontinuations of EMRELIS due to adverse reactions occurred in 30% of patients. Adverse reactions which resulted in permanent discontinuation of EMRELIS in ≥2% included peripheral neuropathy and ILD/pneumonitis. Dosage interruptions due to adverse reactions occurred in 44% of patients. Adverse reactions which required dosage interruption in ≥2% of patients included peripheral neuropathy, fatigue, pneumonia, increased ALT, blurred vision, COVID-19, ILD/pneumonitis, and keratitis. Dose reductions due to adverse reactions occurred in 28% of patients. Adverse reactions which required dose reductions in ≥2% of patients included peripheral neuropathy, fatigue, and keratitis. The most common adverse reactions (≥20%) were peripheral neuropathy, fatigue, decreased appetite, and peripheral edema. The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocytes, increased glucose, increased ALT, increased gamma glutamyl transferase, decreased phosphorus, decreased sodium, decreased hemoglobin and decreased calcium. Table 5 summarizes the adverse reactions in LUMINOSITY. Table 5. Adverse Reactions (≥10%) in Patients with EGFR Wild-Type Non-squamous NSCLC with c-Met Protein Overexpression in LUMINOSITY Adverse Reaction EMRELIS (N=168) All Grades 1 % Grade 3 or 4 1 % Nervous system disorders Peripheral neuropathy 2 51 11 General disorders and administration site conditions Fatigue 2 29 3.6 Peripheral edema 2 22 1.8 Metabolism and nutrition disorders Decreased appetite 22 0.6 Gastrointestinal disorders Nausea 15 0 Constipation 14 0.6 Vomiting 10 0.6 Eye disorders Blurred vision 3 15 1.2 Keratitis 4 11 0.6 Infections and infestations Pneumonia 2 13 6 Respiratory, thoracic and mediastinal disorders ILD/pneumonitis 2 10 3.6 1 Events were graded using NCI CTCAE version 4.03. 2 Grouped term. 3 Includes vision blurred, visual acuity reduced, visual impairment. 4 Includes corneal cyst, corneal disorder, corneal erosion, corneal edema, corneal opacity, keratitis, keratitis interstitial, punctate keratitis. Other clinically relevant adverse reactions in <10% of patients who received EMRELIS included arthralgia, dizziness, dry eye, infusion-related reaction and photophobia. Table 6 presents laboratory abnormalities in LUMINOSITY. Table 6. Select Laboratory Abnormalities (≥10%) that Worsened from Baseline in Patients with EGFR Wild-Type Non-squamous NSCLC with c-Met Protein Overexpression in LUMINOSITY Laboratory Abnormality EMRELIS (N=168) All Grades % Grade 3 or 4 % Chemistry Albumin decreased 61 0.6 Glucose increased 58 4.8 Calcium decreased 47 2.4 Alanine transaminase increased 41 4.8 Gamma glutamyl transferase increased 36 4.3 Aspartate aminotransferase increased 34 0.6 Phosphorus decreased 33 4.2 Sodium decreased 30 3.6 Alkaline phosphatase increased 30 0.6 Creatinine increased 16 1.2 Potassium decreased 14 1.2 Magnesium decreased 14 0.6 Glucose decreased 11 0 Magnesium increased 10 0 Hematology Lymphocytes decreased 37 10 Hemoglobin decreased 35 3.6 White blood cells decreased 16 1.2 Platelets decreased 14 0.6 Neutrophils decreased 10 1.2 Percentages were calculated using patients with worsening laboratory values from baseline and the number of patients with both baseline and post-treatment measurements as the denominator."],"contraindications":["4 CONTRAINDICATIONS None. None. ( 4 )"],"drug_interactions":["7 DRUG INTERACTIONS S trong CYP3A I nhibitors : concomitant use with EMRELIS may increase the AUC of MMAE. Monitor for increased risk of adverse reactions to EMRELIS. ( 7.1 ) 7.1 Effect of Other Drugs on EMRELIS Strong CYP3A Inhibitors Concomitant use with strong CYP3A inhibitors may increase unconjugated MMAE AUC [see Clinical Pharmacology ( 12.3 ) ] , which may increase the risk of EMRELIS adverse reactions. Monitor patients for adverse reactions when EMRELIS is given concomitantly with strong CYP3A inhibitors."],"spl_medguide_table":["<table ID=\"MEDICATIONGUIDE\"><col width=\"396\"/><col width=\"326\"/><tbody><tr><td styleCode=\"Toprule Lrule Rrule \" colspan=\"2\" align=\"center\"><content styleCode=\"bold\">MEDICATION GUIDE</content> EMRELIS&#x2122; (EM-rell-is) (telisotuzumab vedotin-tllv) for injection, for intravenous use</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \" colspan=\"2\"><content styleCode=\"bold\">What is the most important information I should know about EMRELIS?</content> <content styleCode=\"bold\">EMRELIS can cause serious side effects, including:</content><list listType=\"unordered\" styleCode=\"Disc\"><item><content styleCode=\"bold\">Nerve problems in your hands or feet</content><content styleCode=\"bold\"> </content><content styleCode=\"bold\">(peripheral neuropathy). </content>Nerve problems are common during treatment with EMRELIS and can also be severe. Tell your healthcare provider if you develop any new or worsening signs or symptoms of nerve problems, including:</item></list></td></tr><tr><td styleCode=\"Lrule \"><list listType=\"unordered\" styleCode=\"Circle\"><item>numbness </item><item>tingling </item><item>burning sensation</item></list></td><td styleCode=\"Rrule \"><list listType=\"unordered\" styleCode=\"Circle\"><item>pain or discomfort </item><item>muscle weakness </item><item>difficulty walking</item></list></td></tr><tr><td styleCode=\"Lrule Rrule \" colspan=\"2\"><list listType=\"unordered\" styleCode=\"Disc\"><item><content styleCode=\"bold\">Lung problems. </content>EMRELIS can<content styleCode=\"bold\"> </content>cause<content styleCode=\"bold\"> </content>lung problems that may be severe, life-threatening or that may lead to death.<content styleCode=\"bold\"> </content>Tell your healthcare provider right away if you develop new or worsening lung symptoms, including:</item></list></td></tr><tr><td styleCode=\"Lrule \"><list listType=\"unordered\" styleCode=\"Circle\"><item>cough </item><item>trouble breathing or shortness of breath</item></list></td><td styleCode=\"Rrule \"><list listType=\"unordered\" styleCode=\"Circle\"><item>fever </item><item>wheezing</item></list></td></tr><tr><td styleCode=\"Lrule Rrule \" colspan=\"2\"><list listType=\"unordered\" styleCode=\"Disc\"><item><content styleCode=\"bold\">Eye problems.</content> Your healthcare provider may send you to an eye care professional to check your eyes if you develop eye problems. Tell your healthcare provider right away if you develop any new or worsening eye problems or vision changes, including:</item></list></td></tr><tr><td styleCode=\"Lrule \"><list listType=\"unordered\" styleCode=\"Circle\"><item>blurred vision </item><item>dry eyes </item><item>sensitivity to light</item></list></td><td styleCode=\"Rrule \"><list listType=\"unordered\" styleCode=\"Circle\"><item>eye pain or swelling </item><item>eye redness</item></list></td></tr><tr><td styleCode=\"Lrule Rrule \" colspan=\"2\"><list listType=\"unordered\" styleCode=\"Disc\"><item><content styleCode=\"bold\">Infusion-related reactions. </content>EMRELIS can cause infusion reactions that can be severe<content styleCode=\"bold\"> </content>or life-threatening. Tell your healthcare provider right away if you develop any signs and symptoms of infusion reactions, including:</item></list></td></tr><tr><td styleCode=\"Lrule \"><list listType=\"unordered\" styleCode=\"Circle\"><item>itching or rash </item><item>shortness of breath or wheezing </item><item>flushing </item><item>chest discomfort </item><item>fever</item></list></td><td styleCode=\"Rrule \"><list listType=\"unordered\" styleCode=\"Circle\"><item>back pain </item><item>chills </item><item>headache </item><item>nausea or vomiting </item><item>feel like passing out</item></list></td></tr><tr><td styleCode=\"Lrule Rrule \" colspan=\"2\"><content styleCode=\"bold\">Getting medical treatment right away may help keep these problems from becoming more serious. </content>Your healthcare provider will check you for these problems during your treatment with EMRELIS and may provide treatment for your side effects. Your healthcare provider may also need to change your dose, temporarily stop, or completely stop treatment with EMRELIS if you have severe side effects. See<content styleCode=\"bold\"> &#x201C;What are the possible side effects of EMRELIS?&#x201D; </content>for more information about side effects.</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \" colspan=\"2\"><content styleCode=\"bold\">What is EMRELIS?</content> EMRELIS is a prescription medicine used to treat adults with non-squamous non-small cell lung cancer (NSCLC): <list listType=\"unordered\" styleCode=\"Disc\"><item>that has spread to areas near the lungs (locally advanced) or to other parts of the body (metastatic), <content styleCode=\"bold\">and</content> </item><item>whose tumors have high c-Met protein overexpression, <content styleCode=\"bold\">and</content> </item><item>who have received a prior treatment.</item></list>Your healthcare provider will perform a test to make sure EMRELIS is right for you. It is not known if EMRELIS is safe and effective in children.</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \" colspan=\"2\"><content styleCode=\"bold\">Before receiving EMRELIS, tell your healthcare provider about all of your medical conditions, including if you:</content> <list listType=\"unordered\" styleCode=\"Disc\"><item>have a history of nerve problems </item><item>have lung or breathing problems other than your lung cancer </item><item>have eye problems </item><item>have liver problems </item><item>are pregnant or plan to become pregnant. EMRELIS can harm your unborn baby.</item></list><content styleCode=\"bold\">Females who are able to become pregnant:</content> <list listType=\"unordered\" styleCode=\"Circle\"><item>Your healthcare provider should do a pregnancy test before you start treatment with EMRELIS. </item><item>You should use effective birth control (contraception) during treatment and for 2 months after your last dose of EMRELIS. </item><item>Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EMRELIS.</item></list><content styleCode=\"bold\">Males with female partners who are able to become pregnant:</content> <list listType=\"unordered\" styleCode=\"Circle\"><item>You should use an effective birth control during treatment and for 4 months after your last dose of EMRELIS.</item></list><list listType=\"unordered\" styleCode=\"Disc\"><item>are breastfeeding or plan to breastfeed. It is not known if EMRELIS passes into your breast milk. Do not breastfeed during treatment with EMRELIS and for 1 month after the last dose.</item></list><content styleCode=\"bold\">Tell your healthcare provider about all the medicines you take</content>, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking certain medicines with EMRELIS may increase your risk of side effects.</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \" colspan=\"2\"><content styleCode=\"bold\">How will I receive EMRELIS?</content><list listType=\"unordered\" styleCode=\"Disc\"><item>Your healthcare provider will give you EMRELIS into your vein through an intravenous (IV) line over 30 minutes. </item><item>EMRELIS is given 1 time every 2 weeks. </item><item>Your healthcare provider will decide how many infusions of EMRELIS you will receive.</item></list></td></tr><tr><td styleCode=\"Toprule Lrule Rrule \" colspan=\"2\"><content styleCode=\"bold\">What are the possible side effects of EMRELIS?</content> <content styleCode=\"bold\">EMRELIS can cause serious side effects, including:</content> <list listType=\"unordered\" styleCode=\"Disc\"><item>See<content styleCode=\"bold\"> &#x201C;What is the most important information I should know about EMRELIS?&#x201D;</content></item></list><content styleCode=\"bold\">The most common side effects of </content><content styleCode=\"bold\">EMRELIS</content><content styleCode=\"bold\"> include:</content></td></tr><tr><td styleCode=\"Lrule \"><list listType=\"unordered\" styleCode=\"Disc\"><item>feeling tired</item></list></td><td styleCode=\"Rrule \"><list listType=\"unordered\" styleCode=\"Disc\"><item>swelling in the feet, ankles, legs or hands</item></list></td></tr><tr><td styleCode=\"Lrule \"><list listType=\"unordered\" styleCode=\"Disc\"><item>decreased appetite</item></list></td><td styleCode=\"Rrule \"/></tr><tr><td styleCode=\"Lrule Rrule \" colspan=\"2\"><content styleCode=\"bold\">The most common severe abnormal </content><content styleCode=\"bold\">laboratory test results with</content><content styleCode=\"bold\"> EMRELIS include:</content></td></tr><tr><td styleCode=\"Lrule \"><list listType=\"unordered\" styleCode=\"Disc\"><item>decreased white blood cell counts </item><item>increased blood sugar levels </item><item>increased blood liver enzyme levels </item><item>decreased blood phosphorus levels</item></list></td><td styleCode=\"Rrule \"><list listType=\"unordered\" styleCode=\"Disc\"><item>decreased blood sodium levels </item><item>decreased red blood cell counts </item><item>decreased blood calcium levels</item></list></td></tr><tr><td styleCode=\"Lrule Rrule \" colspan=\"2\">EMRELIS may cause fertility problems in females and males, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility. These are not all the possible side effects of EMRELIS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \" colspan=\"2\"><content styleCode=\"bold\">General information about the safe and effective use of EMRELIS.</content> Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about EMRELIS that is written for healthcare professionals.</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \" colspan=\"2\"><content styleCode=\"bold\">What are the ingredients in EMRELIS?</content> <content styleCode=\"bold\">Active ingredient:</content> telisotuzumab vedotin-tllv <content styleCode=\"bold\">Inactive ingredients: </content>histidine, polysorbate 80, sucrose. Hydrochloric acid added to adjust the pH. Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA U.S. License Number: 1889 Marketed by: AbbVie Inc., North Chicago, IL 60064 U.S.A. &#xA9;2025 AbbVie. All rights reserved.  EMRELIS and its design are trademarks of AbbVie Inc. For more information, go to <content styleCode=\"underline\">www.EMRELIS.com</content> or call 1-844-859-5760.</td></tr></tbody></table>"],"mechanism_of_action":["12.1 Mechanism of Action Telisotuzumab vedotin-tllv is a c-Met-directed antibody drug conjugate (ADC). The antibody is a humanized IgG1κ directed against c-Met, the cell surface receptor for hepatocyte growth factor. The small molecule, MMAE, is a microtubule-disrupting agent, attached to the antibody via a protease cleavable linker. Following binding to c-Met-expressing cells, telisotuzumab vedotin-tllv undergoes internalization and intracellular cleavage of MMAE. MMAE disrupts the microtubule network of actively dividing cells, subsequently inducing cell cycle arrest and apoptotic cell death. Telisotuzumab vedotin-tllv exhibited antitumor activity in xenograft models of NSCLC."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Telisotuzumab vedotin-tllv is a c-Met-directed antibody drug conjugate (ADC). The antibody is a humanized IgG1κ directed against c-Met, the cell surface receptor for hepatocyte growth factor. The small molecule, MMAE, is a microtubule-disrupting agent, attached to the antibody via a protease cleavable linker. Following binding to c-Met-expressing cells, telisotuzumab vedotin-tllv undergoes internalization and intracellular cleavage of MMAE. MMAE disrupts the microtubule network of actively dividing cells, subsequently inducing cell cycle arrest and apoptotic cell death. Telisotuzumab vedotin-tllv exhibited antitumor activity in xenograft models of NSCLC. 12.2 Pharmacodynamics Exposure Response Relationships Exposure-response relationships for efficacy and time course of pharmacodynamic response have not been fully characterized. Higher telisotuzumab vedotin-tllv exposure was associated with increased rates of Grade 3 peripheral neuropathy, and Grades 2 and 3 ocular surface disorders. Higher unconjugated MMAE exposure was associated with increased rates of Grade ≥3 adverse reactions and fatal adverse reactions. Cardiac Electrophysiology There is insufficient information to characterize the effect of telisotuzumab vedotin-tllv on the QT interval. 12.3 Pharmacokinetics The exposure parameters of telisotuzumab vedotin-tllv (ADC) and unconjugated MMAE (cytotoxic component of EMRELIS) are summarized in Table 7. The plasma exposure of the ADC and unconjugated MMAE increased proportionally over a dose range of 1.2 to 3.3 mg/kg (0.64 to 1.7 times the approved recommended dose). ADC time to maximum plasma concentrations (Tmax) occurs at the end of intravenous infusion while MMAE Tmax occurs approximately 5 days after EMRELIS administration. Minimal accumulation of the ADC or MMAE occurs. Table 7. Exposure Parameters of Telisotuzumab Vedotin-tllv (ADC) and Unconjugated MMAE at EMRELIS 1.9 mg/kg Every 2 Weeks ADC Unconjugated MMAE C max 29 (43) µg/mL 2.2 (53) ng/mL AUC 0- tau 2,130 (55) µg∙hr/mL 405 (64) ng∙hr/mL C max = maximum concentration AUC 0- tau = area under the concentration-time curve from time zero to 14 days (2 weeks) Distribution The estimated volume of distribution is 3.4 L (16.5%CV) for telisotuzumab vedotin-tllv. MMAE plasma protein binding ranges from 68% to 82% in vitro . Elimination The elimination half-life is approximately 3 days for the ADC and approximately 4 days for MMAE. The estimated clearance (CL) is 1.3 L/day (31.5%CV) for the ADC and 76 L/day (52.1%CV) for MMAE. Metabolism Telisotuzumab vedotin-tllv catabolism has not been studied in humans; however, it is expected to undergo catabolism to small peptides, amino acids, unconjugated MMAE, and unconjugated MMAE-related catabolites. MMAE is metabolized primarily by CYP3A4. Specific Populations No clinically significant differences in the pharmacokinetics of the ADC or unconjugated MMAE were observed based on age (30 to 87 years), sex, race (65% White, 32% Asian, and 3% Black), body weight (34 to 144 kg), mild or moderate renal impairment (CLcr 30 to 89 mL/min, estimated by Cockcroft-Gault), or mild hepatic impairment (total bilirubin ≤ULN and AST >ULN or total bilirubin >ULN and ≤1.5 x ULN and any AST). The effect of severe renal impairment (CLcr <30 mL/min), end-stage renal disease with or without dialysis, or moderate to severe hepatic impairment (total bilirubin >1.5 × ULN and any AST) on the pharmacokinetics of telisotuzumab vedotin-tllv or unconjugated MMAE is unknown. Drug Interaction Studies Clinical Studies and Model-Informed Approaches: No clinical studies have evaluated the potential for drug-drug interactions. Strong CYP3A4 Inhibitor: MMAE AUC is predicted to increase by 1.4-fold following concomitant administration of EMRELIS with ketoconazole (a strong CYP3A inhibitor). Strong CYP3A4 Inducer: MMAE AUC is predicted to decrease by 70% following concomitant administration of EMRELIS with rifampicin (a strong CYP3A inducer). Sensitive CYP3A Substrate: No clinically significant difference in the pharmacokinetics of midazolam (a sensitive CYP3A substrate) is predicted when used concomitantly with EMRELIS. In Vitro Studies Cytochrome P450 (CYP) Enzymes: MMAE is a substrate and an inhibitor of CYP3A4/5. Transporter Systems: MMAE is a substrate of P-glycoprotein (P-gp). 12.6 Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the study described below with the incidence of anti-drug antibodies in other studies, including those of EMRELIS or of other telisotuzumab products. Following administration of EMRELIS in LUMINOSITY, 22% (60/269) of patients tested positive for treatment-emergent antibodies against telisotuzumab vedotin-tllv at one or more post-baseline time points. Of those who tested positive for anti-drug antibody, neutralizing antibodies were detected in 38% (23/60) of patients. Development of anti-drug antibodies and neutralizing antibodies resulted in a 17% decrease in clearance of telisotuzumab vedotin-tllv. There are insufficient data to assess whether the observed anti-telisotuzumab vedotin-tllv antibody-associated pharmacokinetic changes affect the safety and effectiveness of EMRELIS."],"indications_and_usage":["1 INDICATIONS AND USAGE EMRELIS is indicated for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test [see Dosage and Administration ( 2.1 )] , who have received a prior systemic therapy . This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR) [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). EMRELIS is a c-Met-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy. ( 1 ) This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )"],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS Peripheral Neuropathy : Monitor patients for new or worsening peripheral neuropathy. Withhold, reduce the dose, or permanently discontinue EMRELIS based on the severity. ( 5.1 ) I nterstitial Lung Disease (ILD)/ Pneumonitis : Severe, life-threatening or fatal ILD/pneumonitis may occur. Withhold or permanently discontinue EMRELIS based on the severity. ( 5.2 ) Ocular Surface Disorders : Monitor patients for signs or symptoms of ocular surface disorders, including vision changes. Withhold or permanently discontinue EMRELIS based on the severity. ( 5.3 ) Infusion - Related Reactions (IRR) : Monitor patients for IRR. Withhold, reduce the rate of infusion, or permanently discontinue EMRELIS based on the severity. For patients who experience IRR, administer premedications prior to subsequent infusions. ( 5.4 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients about the potential risk to a fetus and to use effective contraception. ( 5.5 ) 5.1 Peripheral Neuropathy EMRELIS can cause peripheral neuropathy, including peripheral sensory neuropathy and peripheral motor neuropathy. In the safety population [see Adverse Reactions ( 6.1 )], peripheral neuropathy occurred in 51% of patients treated with EMRELIS, including Grade 3 in 11%. These adverse reactions included peripheral sensory neuropathy in 45% of patients and peripheral motor neuropathy in 9%. The median time to onset of peripheral neuropathy was 105 days (range: 1 to 472 days). Peripheral neuropathy led to permanent discontinuation of EMRELIS in 13% of patients. The median time to onset of peripheral neuropathy leading to treatment discontinuation was 249 days (range: 57 to 519 days). Of the 7 patients with motor neuropathy ongoing as of their last dose of EMRELIS, 6 had persistent Grade 1 or 2 symptoms 30 days after their last dose. Monitor patients for signs and symptoms of new or worsening peripheral neuropathy such as hypoesthesia, hyperesthesia, paresthesia, a burning sensation, neuropathic pain, or muscle weakness. Withhold, reduce the dose or permanently discontinue EMRELIS based on severity [see Dosage and Administration ( 2.3 )]. 5.2 Interstitial Lung Disease /Pneumonitis EMRELIS can cause severe, life-threatening, or fatal interstitial lung disease (ILD)/pneumonitis. In the safety population [see Adverse Reactions ( 6.1 )], ILD/pneumonitis occurred in 10% of patients treated with EMRELIS, including Grade 3 in 3% and Grade 4 in 0.6%. There were 3 fatal cases of ILD/pneumonitis in patients who received EMRELIS. The median time to onset of ILD/pneumonitis was 48 days (range: 23 to 85 days). ILD/pneumonitis led to permanent discontinuation of EMRELIS in 7% of patients. The median time to onset of ILD/pneumonitis leading to treatment discontinuation was 46 days (range: 23 to 85 days). Advise patients to immediately report cough, dyspnea, fever, and/or any new or worsening respiratory symptoms. Monitor patients for signs and symptoms of ILD/pneumonitis. Withhold or permanently discontinue EMRELIS based on severity [see Dosage and Administration ( 2.3 )]. 5.3 Ocular Surface Disorders EMRELIS can cause ocular surface disorders including blurred vision, visual impairment, keratitis, and dry eye. In the safety population [see Adverse Reactions ( 6.1 )], ocular surface disorders occurred in 25% of patients treated with EMRELIS. The most common ocular surface disorders were blurred vision (15%), keratitis (11%), and dry eye (5%). Grade 3 ocular surface disorders occurred in 1.2% of patients [blurred vision (1.2%), and keratitis (0.6%)]. The median time to onset of ocular surface disorders was 47 days (range: 1 to 319 days). Monitor patients for ocular surface disorders during treatment with EMRELIS. Withhold EMRELIS and refer patients to an eye care professional for an ophthalmic examination and treatment for patients who develop Grade ≥2 ocular toxicity. Withhold or permanently discontinue EMRELIS based on severity [see Dosage and Administration ( 2.3 )]. 5.4 Infusion - Related Reactions EMRELIS can cause infusion-related reactions (IRR); signs and symptoms of IRR include dyspnea, flushing, chills, nausea, chest discomfort, and hypotension. The median time to onset of IRR was 28 days (range: 1 to 43 days). In the safety population, [see Adverse Reactions ( 6.1 )] , IRR occurred in 3% of patients treated with EMRELIS including Grade 3 in 1.2% and Grade 4 in 0.6%. IRR led to permanent discontinuation of EMRELIS in 0.6% of patients. Monitor patients for signs and symptoms of infusion reactions during EMRELIS infusion. Withhold, reduce the rate of infusion, or permanently discontinue EMRELIS based on severity [see Dosage and Administration ( 2.3 )]. For patients who experience IRR, administer premedications prior to subsequent infusions. 5. 5 Embryo-Fetal Toxicity Based on the mechanism of action and findings in animals, EMRELIS can cause fetal harm when administered to a pregnant woman. The small molecule component of EMRELIS, MMAE, administered to rats caused adverse developmental outcomes, including embryo-fetal mortality and structural abnormalities, at exposures similar to those occurring clinically at the recommended dose. Advise patients of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with EMRELIS and for 2 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with EMRELIS and for 4 months after the last dose [see Use in Specific Populations ( 8.1 , 8.3 ) and Clinical Pharmacology ( 12.1 )]."],"clinical_studies_table":["<table><caption>Table 8. Efficacy Results in LUMINOSITY for Patients with EGFR Wild-Type Non-squamous NSCLC with High c-Met Protein Overexpression</caption><col width=\"393\"/><col width=\"234\"/><tbody><tr><td styleCode=\"Toprule Lrule Rrule \"><content styleCode=\"bold\">Efficacy Parameter</content><content styleCode=\"bold\"> </content></td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\"><content styleCode=\"bold\">EMRELIS</content> <content styleCode=\"bold\">N = </content><content styleCode=\"bold\">84</content></td></tr><tr><td styleCode=\"Toprule Lrule Rrule \"><content styleCode=\"bold\">Confirmed </content><content styleCode=\"bold\">Overall Response Rate</content> <content styleCode=\"bold\">(ORR)</content>, % (95% CI) </td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">35 (24, 46)</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \"> Complete Response, %</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">0</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \"> Partial Response, %</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">35</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \"><content styleCode=\"bold\">Duration of Response</content></td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\"><content styleCode=\"bold\">N = 29</content></td></tr><tr><td styleCode=\"Toprule Lrule Rrule \"> Median, months   (95% CI)</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">7.2 (4.2, 12)</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \"> DOR &#x2265;6 months,<sup>a</sup> % </td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">59</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \"> DOR &#x2265;12 months,<sup>a</sup><sup> </sup>%</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">21</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \" colspan=\"2\">CI=confidence interval; DOR=duration of response <sup>a</sup><sup> </sup>Based on observed duration of response in 29 responders.</td></tr></tbody></table>"],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies in animals have not been performed with telisotuzumab vedotin-tllv or the small molecule MMAE. Mutagenesis MMAE was positive for genotoxicity in the in vivo rat bone marrow micronucleus study through an aneugenic mechanism. MMAE was not mutagenic in the bacterial reverse mutation (Ames) assay or the L5178Y TK +/- mouse lymphoma forward mutation assay. Impairment of Fertility Fertility studies with telisotuzumab vedotin-tllv or MMAE have not been conducted. However, results of repeat-dose toxicity studies in rats and monkeys indicate the potential for telisotuzumab vedotin-tllv to impair male and female reproductive function and fertility. In a 2-week repeat-dose toxicology study in rats, telisotuzumab vedotin-tllv administered at doses ≥6 mg/kg (≥12 times the human exposure [AUC] at the recommended dose) resulted in decreased number/degeneration of germ cells in the testes largely due to loss of spermatogonia. The reversibility of these findings was not assessed. In a 4-week repeat-dose toxicology study in sexually immature monkeys, telisotuzumab vedotin-tllv administered at doses ≥3 mg/kg (≥4 times the human exposure [AUC] at the recommended dose) resulted in degeneration of granulosa cells and decreased number of tertiary follicles in the ovaries and degeneration/necrosis of endometrial glands in the uterus. There was evidence of reversibility after an 8-week recovery period."],"pharmacokinetics_table":["<table><caption>Table 7. Exposure Parameters of Telisotuzumab Vedotin-tllv (ADC) and Unconjugated MMAE at EMRELIS 1.9 mg/kg Every 2 Weeks</caption><col width=\"114\"/><col width=\"166\"/><col width=\"234\"/><tbody><tr><td styleCode=\"Toprule Lrule Rrule \"/><td styleCode=\"Toprule Lrule Rrule \" align=\"center\"><content styleCode=\"bold\">ADC</content></td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\"><content styleCode=\"bold\">Unconjugated MMAE</content></td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">C<sub>max </sub></td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">29 (43) &#xB5;g/mL</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">2.2 (53) ng/mL</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">AUC<sub>0-</sub><sub>tau</sub></td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">2,130 (55) &#xB5;g&#x2219;hr/mL</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">405 (64) ng&#x2219;hr/mL</td></tr></tbody></table>"],"adverse_reactions_table":["<table><caption>Table 5. Adverse Reactions (&#x2265;10%) in Patients with EGFR Wild-Type Non-squamous NSCLC with c-Met Protein Overexpression in LUMINOSITY</caption><col width=\"406\"/><col width=\"116\"/><col width=\"115\"/><tbody><tr><td styleCode=\"Toprule Lrule Rrule \"><content styleCode=\"bold\">Adverse Reaction</content></td><td styleCode=\"Toprule Lrule Rrule \" colspan=\"2\" valign=\"bottom\" align=\"center\"><content styleCode=\"bold\">EMRELIS</content> <content styleCode=\"bold\">(N=168)</content></td></tr><tr><td styleCode=\"Lrule Rrule \" valign=\"bottom\"/><td styleCode=\"Toprule Lrule Rrule \" valign=\"bottom\" align=\"center\"><content styleCode=\"bold\">All Grades</content><content styleCode=\"bold\"><sup>1</sup></content> <content styleCode=\"bold\">%</content></td><td styleCode=\"Toprule Lrule Rrule \" valign=\"bottom\" align=\"center\"><content styleCode=\"bold\">Grade 3 or 4</content><content styleCode=\"bold\"><sup>1</sup></content> <content styleCode=\"bold\">%</content></td></tr><tr><td styleCode=\"Toprule Lrule \"><content styleCode=\"bold\">Nervous system disorders</content></td><td styleCode=\"Toprule \" align=\"center\"/><td styleCode=\"Toprule Rrule \" align=\"center\"/></tr><tr><td styleCode=\"Toprule Lrule Rrule \"> Peripheral neuropathy<sup>2</sup></td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">51</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">11</td></tr><tr><td styleCode=\"Toprule Lrule \" colspan=\"2\"><content styleCode=\"bold\">General disorders and administration site conditions</content></td><td styleCode=\"Toprule Rrule \" align=\"center\"/></tr><tr><td styleCode=\"Toprule Lrule Rrule \"> Fatigue<sup>2</sup></td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">29</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">3.6</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \"> Peripheral edema<sup>2</sup></td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">22</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">1.8</td></tr><tr><td styleCode=\"Toprule Lrule \"><content styleCode=\"bold\">Metabolism and nutrition disorders</content></td><td styleCode=\"Toprule \" valign=\"bottom\" align=\"center\"/><td styleCode=\"Toprule Rrule \" valign=\"bottom\" align=\"center\"/></tr><tr><td styleCode=\"Toprule Lrule Rrule \"> Decreased appetite</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">22</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">0.6</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \" colspan=\"3\"><content styleCode=\"bold\">Gastrointestinal disorders</content></td></tr><tr><td styleCode=\"Toprule Lrule Rrule \"> Nausea</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">15</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">0</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \"> Constipation</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">14</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">0.6</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \"> Vomiting</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">10</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">0.6</td></tr><tr><td styleCode=\"Toprule Lrule \"><content styleCode=\"bold\">Eye disorders</content></td><td styleCode=\"Toprule \" align=\"center\"/><td styleCode=\"Toprule Rrule \" align=\"center\"/></tr><tr><td styleCode=\"Toprule Lrule Rrule \"><content styleCode=\"bold\"> </content>Blurred vision<sup>3</sup></td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">15</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">1.2</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \"><content styleCode=\"bold\"> </content>Keratitis<sup>4</sup></td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">11</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">0.6</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \" colspan=\"3\"><content styleCode=\"bold\">Infections and infestations</content></td></tr><tr><td styleCode=\"Toprule Lrule Rrule \"> Pneumonia<sup>2</sup></td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">13</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">6</td></tr><tr><td styleCode=\"Toprule Lrule \" colspan=\"2\"><content styleCode=\"bold\">Respiratory, thoracic and mediastinal disorders</content></td><td styleCode=\"Toprule Rrule \" valign=\"bottom\" align=\"center\"/></tr><tr><td styleCode=\"Toprule Lrule Rrule \"> ILD/pneumonitis<sup>2</sup></td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">10</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">3.6</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \" colspan=\"3\"><sup>1</sup>Events were graded using NCI CTCAE version 4.03. <sup>2</sup>Grouped term. <sup>3</sup>Includes vision blurred, visual acuity reduced, visual impairment. <sup>4</sup>Includes corneal cyst, corneal disorder, corneal erosion, corneal edema, corneal opacity, keratitis, keratitis interstitial, punctate keratitis.</td></tr></tbody></table>","<table><caption>Table 6. Select Laboratory Abnormalities (&#x2265;10%) that Worsened from Baseline in Patients with EGFR Wild-Type Non-squamous NSCLC with c-Met Protein Overexpression in LUMINOSITY</caption><col width=\"298\"/><col width=\"126\"/><col width=\"144\"/><tbody><tr><td styleCode=\"Toprule Lrule Rrule \"><content styleCode=\"bold\">Laboratory </content><content styleCode=\"bold\">Abnormality</content></td><td styleCode=\"Toprule Lrule Rrule \" colspan=\"2\" align=\"center\"><content styleCode=\"bold\">EMRELIS</content> <content styleCode=\"bold\">(N=168)</content></td></tr><tr><td styleCode=\"Lrule Rrule \"/><td styleCode=\"Toprule Lrule Rrule \" align=\"center\"><content styleCode=\"bold\">All Grades</content> <content styleCode=\"bold\">%</content></td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\"><content styleCode=\"bold\">Grade 3 or 4</content> <content styleCode=\"bold\">%</content></td></tr><tr><td styleCode=\"Toprule Lrule Rrule \" colspan=\"3\"><content styleCode=\"bold\">Chemistry</content></td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Albumin decreased</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">61</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">0.6</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Glucose increased</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">58</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">4.8</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Calcium decreased</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">47</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">2.4</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Alanine transaminase increased</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">41</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">4.8</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Gamma glutamyl transferase increased</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">36</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">4.3</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Aspartate aminotransferase increased</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">34</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">0.6</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Phosphorus decreased</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">33</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">4.2</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Sodium decreased</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">30</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">3.6</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Alkaline phosphatase increased</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">30</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">0.6</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Creatinine increased</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">16</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">1.2</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Potassium decreased</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">14</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">1.2</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Magnesium decreased</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">14</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">0.6</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Glucose decreased</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">11</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">0</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Magnesium increased</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">10</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">0</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \" colspan=\"3\"><content styleCode=\"bold\">Hematology</content></td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Lymphocytes decreased</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">37</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">10</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Hemoglobin decreased</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">35</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">3.6</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">White blood cells decreased</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">16</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">1.2</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Platelets decreased</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">14</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">0.6</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Neutrophils decreased</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">10</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">1.2</td></tr></tbody></table>"],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Peripheral Neuropathy Advise patients that EMRELIS can cause peripheral neuropathy. Advise patients to report to their healthcare provider any new or worsening numbness or tingling of the hands or feet or any muscle weakness [see Warnings and Precautions ( 5.1 )]. ILD/Pneumonitis Advise patients that EMRELIS can cause ILD/pneumonitis. Advise patients to immediately report to their healthcare provider any new or worsening respiratory symptoms [see Warnings and Precautions ( 5.2 )]. Ocular Surface Disorders Advise patients that EMRELIS can cause ocular surface disorders. Advise patients to contact their healthcare provider any new or worsening ocular problems or vision changes [see Warnings and Precautions ( 5.3 )]. Infusion -Related Reactions Advise patients that EMRELIS can cause infusion-related reactions. Advise patients to immediately contact their healthcare provider if they experience signs and symptoms of infusion reactions, including fever, chills, rash, or breathing problems [see Warnings and Precautions ( 5.4 )]. Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise female patients to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, during treatment with EMRELIS [see Warnings and Precautions ( 5.5 ) and Use in Specific Populations ( 8.1 )]. Females and Males of Reproductive Potential Advise females of reproductive potential to use effective contraception during treatment and for 2 months after the last dose [see Use in Specific Populations ( 8.3 )] . Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the last dose [see Use in Specific Populations ( 8.3 )]. Lactation Advise women not to breastfeed during treatment with EMRELIS and for 1 month after the last dose [see Use in Specific Populations ( 8.2 )]. Infertility Advise males and females of reproductive potential that EMRELIS may impair fertility [see Nonclinical Toxicology ( 13 ) ]. EMRELIS™ [telisotuzumab vedotin-tllv] Manufactured by: AbbVie Inc. North Chicago, IL 60064, U.S.A. U.S. License No. 1889 © 2025 AbbVie. All rights reserved. EMRELIS and its design are trademarks of AbbVie Inc. 20090524"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION For intravenous infusion only. ( 2.5 ) The recommended dosage of EMRELIS is 1.9 mg/kg administered intravenously every 2 weeks until disease progression or unacceptable toxicity. ( 2.2 ) Reconstitute and further dilute EMRELIS prior to intravenous infusion. ( 2.5 ) 2.1 Patient Selection Select patients for treatment with EMRELIS based on the presence of high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining] in patients with non-squamous NSCLC [see Indications and Usage ( 1 ) and Clinical Studies ( 14 )] . Information on FDA-approved tests for the detection of high c-Met protein overexpression is available at: http://www.fda.gov/CompanionDiagnostics. 2.2 Recommended Dosage The recommended dosage of EMRELIS is 1.9 mg/kg (up to a maximum of 190 mg for patients greater than or equal to 100 kg) administered as an intravenous infusion over 30 minutes every 2 weeks until disease progression or unacceptable toxicity. 2.3 Dosage Modifications for Adverse Reactions The recommended dose reductions for adverse reactions are provided in Table 1. Table 1. Recommended Dose Reductions Dose Reduction Recommended Dosage First 1.6 mg/kg every 2 weeks Second 1.3 mg/kg every 2 weeks Third 1 mg/kg every 2 weeks Permanently discontinue EMRELIS in patients who are unable to tolerate 1 mg/kg. The recommended dosage modifications of EMRELIS for adverse reactions are provided in Table 2. Table 2. EMRELIS Dosage Modifications and Management for Adverse Reactions Adverse Reaction Severity a Dosage Modification Peripheral Neuropathy [see Warnings and Precautions ( 5.1 )] Grade 2 or 3 Withhold EMRELIS until recovery to Grade ≤1. Resume EMRELIS at the next lower dose level. Grade 4 Permanently discontinue EMRELIS. Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions ( 5.2 )] Grade 1 Withhold EMRELIS and consider corticosteroids as soon as ILD/pneumonitis is suspected. Resume EMRELIS upon radiographic resolution. Grade ≥2 Permanently discontinue EMRELIS. Keratitis [see Warnings and Precautions ( 5.3 )] Grade 2 Withhold EMRELIS. Refer patients to an eye care professional for an ophthalmic examination and treatment (e.g., lubricating and/or steroidal eye drops). Resume EMRELIS at the same dose at the discretion of the healthcare provider. Grade 3 or 4 Refer patients to an eye care professional for an ophthalmic examination and treatment (e.g., lubricating and/or steroidal eye drops). Permanently discontinue EMRELIS. Infusion-Related Reactions (IRR) [see Warnings and Precautions ( 5.4 )] Grade 1-3 Interrupt EMRELIS infusion and administer supportive treatment. Resume the infusion at a 50% rate reduction. Increase infusion rate as tolerated for subsequent doses. For patients who experience an IRR, administer premedications prior to all future doses (see Table 3 ). Grade 4 Permanently discontinue EMRELIS. Administer supportive treatment. Peripheral Edema [see Adverse Reactions ( 6.1 )] Grade ≥2 First occurrence Withhold EMRELIS until recovery to Grade ≤1. Resume EMRELIS at the same dose level. Subsequent occurrence Withhold EMRELIS until recovery to Grade ≤1. Resume EMRELIS at the next lower dose level. Other Adverse Reactions [see Adverse Reactions ( 6.1 )] Grade 3 First occurrence Withhold EMRELIS until recovery to Grade ≤1. Resume EMRELIS at the same dose. Subsequent occurrence Withhold EMRELIS until recovery to Grade ≤1. Resume EMRELIS at the next lower dose level. Grade 4 Permanently discontinue EMRELIS. a Adverse reactions were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 2. 4 Recommended Premedications for Patients Who Experience Infusion-Related Reactions Table 3 contains the recommended premedications for patients who experience infusion-related reactions to EMRELIS, for subsequent infusions. Table 3: Recommended Premedications for Patients Who Experience Infusion-Related Reactions Medication Class E xamples or equivalent Dose Route of Administration Dosing Window Prior to EMRELIS Administration H1 Antihistamine Diphenhydramine 25 to 50 mg Intravenously or orally Administer 30-60 minutes prior to each infusion H2 Antihistamine Famotidine 20 mg Intravenously or orally Administer 30-60 minutes prior to each infusion Antipyretic Acetaminophen 650 to 1,000 mg Intravenously or orally Administer 30-60 minutes prior to each infusion Glucocorticoid Methylprednisolone 125 mg or equivalent Intravenously Administer 30-60 minutes prior to each infusion 2. 5 Preparation and Administration EMRELIS contains a hazardous component. Follow applicable special handling and disposal procedures in accordance with local requirements. 1 Reconstitute and further dilute EMRELIS prior to intravenous infusion. Reconstitution of Lyophilized EMRELIS Before reconstitution, allow the vial to reach room temperature after removal of the vial from storage condition. Calculate the recommended dose based on the patient’s weight to determine the number of vials needed. For patients weighing greater than or equal to 100 kg, use 190 mg dose [see Dosage and Administration ( 2.2 )] . More than one vial may be needed to achieve the calculated dose. Using a sterile syringe, slowly inject Sterile Water for Injection, using the volume provided in Table 4, into the EMRELIS vial containing the lyophilized powder, which has a whole or fragmented cake-like appearance. The reconstituted solution has a concentration of 20 mg/mL EMRELIS. Table 4. Reconstitution Volumes Dose Vial Volume of Sterile Water for Injection required for reconstitution 20 mg vial 1.1 mL 100 mg vial 5.2 mL Swirl the vial gently until completely dissolved. Do not shake. Inspect the reconstituted solution for particulate matter and discoloration. The solution should appear clear to slightly opalescent and colorless to slightly yellow. Discard the vial if the reconstituted solution is discolored, is cloudy, or contains visible particulates. Use reconstituted EMRELIS immediately. If not used immediately, store the reconstituted EMRELIS vials in a refrigerator at 2°C to 8°C (36°F to 46°F) for up to 24 hours from the time of reconstitution. Do not freeze. Each vial of EMRELIS is intended for one-time use only. Discard any unused drug remaining in the vial. Dilution in Infusion Bag Calculate the required dose volume (mL) of reconstituted EMRELIS solution based on the prescribed dose. Withdraw the calculated dose volume (mL) of reconstituted solution from the EMRELIS vial using a sterile syringe. Discard any unused portion remaining in the vial(s). Inject the calculated amount of reconstituted solution into 0.9% Sodium Chloride Injection infusion bag so that the final EMRELIS concentration is between 1 mg/mL and 10 mg/mL. Use only 0.9% Sodium Chloride Injection. Gently invert the infusion bag to thoroughly mix the solution. Do not shake. After preparing the dose for infusion, visually inspect the bag content for particulates and discard if present. If not used immediately, the diluted solution can be stored in a refrigerator at 2°C to 8°C (36°F to 46°F) for up to 24 hours and an additional 4 hours at room temperature at 9°C to 30°C (48°F to 86°F) until the end of administration. Do not freeze. Method of Administration If the prepared infusion solution was stored refrigerated at 2°C to 8°C (36°F to 46°F), allow the solution to reach room temperature prior to administration. Administer by intravenous infusion over 30 minutes using a dedicated infusion line with a 0.20 or 0.22 micron in-line filter made of polyether sulfone (PES), polyvinylidene fluoride (PVDF), or Polyamide (PA). Do not mix EMRELIS with other drugs or administer other drugs through the same intravenous line."],"spl_product_data_elements":["EMRELIS Telisotuzumab Vedotin TELISOTUZUMAB VEDOTIN TELISOTUZUMAB VEDOTIN HISTIDINE POLYSORBATE 80 SUCROSE WATER HYDROCHLORIC ACID EMRELIS Telisotuzumab Vedotin TELISOTUZUMAB VEDOTIN TELISOTUZUMAB VEDOTIN HISTIDINE SUCROSE POLYSORBATE 80 WATER HYDROCHLORIC ACID"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS For injection: 20 mg or 100 mg of telisotuzumab vedotin-tllv as a white to off-white, lyophilized powder in a single-dose vial for reconstitution and further dilution. For injection: 20 mg or 100 mg of telisotuzumab vedotin-tllv as a lyophilized powder in a single-dose vial. ( 3 )"],"clinical_pharmacology_table":["<table><caption>Table 7. Exposure Parameters of Telisotuzumab Vedotin-tllv (ADC) and Unconjugated MMAE at EMRELIS 1.9 mg/kg Every 2 Weeks</caption><col width=\"114\"/><col width=\"166\"/><col width=\"234\"/><tbody><tr><td styleCode=\"Toprule Lrule Rrule \"/><td styleCode=\"Toprule Lrule Rrule \" align=\"center\"><content styleCode=\"bold\">ADC</content></td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\"><content styleCode=\"bold\">Unconjugated MMAE</content></td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">C<sub>max </sub></td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">29 (43) &#xB5;g/mL</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">2.2 (53) ng/mL</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">AUC<sub>0-</sub><sub>tau</sub></td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">2,130 (55) &#xB5;g&#x2219;hr/mL</td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">405 (64) ng&#x2219;hr/mL</td></tr></tbody></table>"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS Severe or Moderate Hepatic I mpairment : Avoid use of EMRELIS. ( 8.6 ) Lactation : Advise not to breastfeed. ( 8.2 ) Infertility : May impair fertility. ( 8.3 ) 8.1 Pregnancy Risk Summary Based on the mechanism of action and findings in animals, EMRELIS can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available human data on EMRELIS use in pregnant women to inform a drug-associated risk. In an animal reproduction study, administration of the small molecule component of EMRELIS, MMAE, to pregnant rats during organogenesis resulted in embryo-fetal mortality and structural abnormalities at exposures similar to the clinical exposure at the recommended dose [see Data ] . Advise patients of the potential risks to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data No embryo-fetal development studies in animals have been performed with telisotuzumab vedotin-tllv. In an embryo-fetal development study in pregnant rats, administration of two intravenous doses of MMAE, the small molecule component of EMRELIS, on gestational days 6 and 13 caused embryo-fetal mortality and structural abnormalities, including protruding tongue, agnathia, malrotated limbs, and gastroschisis compared to controls at a dose of 0.2 mg/kg (approximately 2 times the human area under the curve [AUC] at the recommended dose). 8.2 Lactation Risk Summary There are no data on the presence of telisotuzumab vedotin-tllv or MMAE in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise lactating women not to breastfeed during treatment with EMRELIS and for 1 month after the last dose. 8.3 Females and Males of Reproductive Potential EMRELIS can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1 ) ] . Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating EMRELIS treatment. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with EMRELIS and for 2 months after the last dose. Males Based on genotoxicity findings, advise male patients with female partners of reproductive potential to use effective contraception during treatment with EMRELIS and for 4 months after the last dose. Infertility Females Based on findings in animal studies with MMAE-containing antibody-drug conjugates (ADCs), EMRELIS may impair female fertility. The effect on fertility is reversible [see Nonclinical Toxicology ( 13.1 )] . Males Based on findings from animal studies, EMRELIS may impair male fertility. The reversibility of this effect is unknown [see Nonclinical Toxicology ( 13.1 )] . 8.4 Pediatric Use Safety and effectiveness of EMRELIS have not been established in pediatric patients. 8.5 Geriatric Use Of the 168 patients with previously treated EGFR wild-type non-squamous NSCLC with c-Met protein overexpression treated with EMRELIS in LUMINOSITY, 50% were ≥65 years of age and 12% were ≥75 years of age. No overall differences in safety or effectiveness were observed between older and younger patients. 8.6 Hepatic Impairment Avoid use of EMRELIS in patients with moderate or severe hepatic impairment (total bilirubin >1.5 x ULN and any AST). Patients with moderate or severe hepatic impairment are likely to have increased exposure to MMAE, which may increase the risk of adverse reactions. EMRELIS has not been studied in patients with moderate or severe hepatic impairment. No dosage adjustment is recommended for patients with mild hepatic impairment (total bilirubin ≤ULN and AST >ULN or total bilirubin >ULN and ≤1.5 x ULN and any AST) [see Clinical Pharmacology ( 12.3 ) ] ."],"dosage_and_administration_table":["<table><caption>Table 1. Recommended Dose Reductions</caption><col width=\"192\"/><col width=\"443\"/><tbody><tr><td styleCode=\"Toprule Lrule Rrule \"><content styleCode=\"bold\">Dose Reduction</content></td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\"><content styleCode=\"bold\">Recommended</content><content styleCode=\"bold\"> </content><content styleCode=\"bold\">Dosage</content></td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">First </td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">1.6 mg/kg every 2 weeks</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Second </td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">1.3 mg/kg every 2 weeks</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Third </td><td styleCode=\"Toprule Lrule Rrule \" align=\"center\">1 mg/kg every 2 weeks</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \" colspan=\"2\">Permanently discontinue EMRELIS in patients who are unable to tolerate 1 mg/kg.</td></tr></tbody></table>","<table><caption>Table 2. EMRELIS Dosage Modifications and Management for Adverse Reactions</caption><col width=\"291\"/><col width=\"138\"/><col width=\"290\"/><tbody><tr><td styleCode=\"Toprule Lrule Rrule \"><content styleCode=\"bold\">Adverse Reaction</content></td><td styleCode=\"Toprule Lrule Rrule \"><content styleCode=\"bold\">Severity</content><content styleCode=\"bold\"><sup>a</sup></content></td><td styleCode=\"Toprule Lrule Rrule \"><content styleCode=\"bold\">Dosage Modification</content></td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Peripheral Neuropathy <content styleCode=\"italics\">[see Warnings and Precautions (</content><content styleCode=\"italics\"><linkHtml href=\"#_5_1_Peripheral_Neuropathy\">5.1</linkHtml></content><content styleCode=\"italics\">)]</content></td><td styleCode=\"Toprule Lrule Rrule \">Grade 2 or 3</td><td styleCode=\"Toprule Lrule Rrule \"><list listType=\"unordered\" styleCode=\"Disc\"><item>Withhold EMRELIS until recovery to Grade &#x2264;1. </item><item>Resume EMRELIS at the next lower dose level.</item></list></td></tr><tr><td styleCode=\"Lrule Rrule \"/><td styleCode=\"Toprule Lrule Rrule \">Grade 4</td><td styleCode=\"Toprule Lrule Rrule \">Permanently discontinue EMRELIS.</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Interstitial Lung Disease (ILD)/Pneumonitis <content styleCode=\"italics\">[see Warnings and Precautions (</content><content styleCode=\"italics\"><linkHtml href=\"#_5_2_Interstitial_Lung\">5.2</linkHtml></content><content styleCode=\"italics\">)]</content></td><td styleCode=\"Toprule Lrule Rrule \">Grade 1</td><td styleCode=\"Toprule Lrule Rrule \"><list listType=\"unordered\" styleCode=\"Disc\"><item>Withhold EMRELIS and consider corticosteroids as soon as ILD/pneumonitis is suspected. </item><item>Resume EMRELIS upon radiographic resolution.</item></list></td></tr><tr><td styleCode=\"Lrule Rrule \"/><td styleCode=\"Toprule Lrule Rrule \">Grade &#x2265;2</td><td styleCode=\"Toprule Lrule Rrule \">Permanently discontinue EMRELIS.</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Keratitis <content styleCode=\"italics\">[see Warnings and Precautions (</content><content styleCode=\"italics\"><linkHtml href=\"#_5_3_Ocular_Surface\">5.3</linkHtml></content><content styleCode=\"italics\">)]</content></td><td styleCode=\"Toprule Lrule Rrule \">Grade 2</td><td styleCode=\"Toprule Lrule Rrule \"><list listType=\"unordered\" styleCode=\"Disc\"><item>Withhold EMRELIS. </item><item>Refer patients to an eye care professional for an ophthalmic examination and treatment (e.g., lubricating and/or steroidal eye drops). </item><item>Resume EMRELIS at the same dose at the discretion of the healthcare provider.</item></list></td></tr><tr><td styleCode=\"Lrule Rrule \"/><td styleCode=\"Toprule Lrule Rrule \">Grade 3 or 4</td><td styleCode=\"Toprule Lrule Rrule \"><list listType=\"unordered\" styleCode=\"Disc\"><item>Refer patients to an eye care professional for an ophthalmic examination and treatment (e.g., lubricating and/or steroidal eye drops). </item><item>Permanently discontinue EMRELIS.</item></list></td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Infusion-Related Reactions (IRR) <content styleCode=\"italics\">[see Warnings and Precautions (</content><content styleCode=\"italics\"><linkHtml href=\"#_5_4_Infusion_Related_Reactions\">5.4</linkHtml></content><content styleCode=\"italics\">)]</content></td><td styleCode=\"Toprule Lrule Rrule \">Grade 1-3</td><td styleCode=\"Toprule Lrule Rrule \"><list listType=\"unordered\" styleCode=\"Disc\"><item>Interrupt EMRELIS infusion and administer supportive treatment. </item><item>Resume the infusion at a 50% rate reduction. Increase infusion rate as tolerated for subsequent doses. </item><item>For patients who experience an IRR, administer premedications prior to all future doses <content styleCode=\"italics\">(see Table </content><content styleCode=\"italics\">3</content><content styleCode=\"italics\">).</content></item></list></td></tr><tr><td styleCode=\"Lrule Rrule \"/><td styleCode=\"Toprule Lrule Rrule \">Grade 4</td><td styleCode=\"Toprule Lrule Rrule \"><list listType=\"unordered\" styleCode=\"Disc\"><item>Permanently discontinue EMRELIS.  </item><item>Administer supportive treatment.</item></list></td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Peripheral Edema <content styleCode=\"italics\">[see Adverse Reactions (</content><content styleCode=\"italics\"><linkHtml href=\"#_6_1__Clinical\">6.1</linkHtml></content><content styleCode=\"italics\">)]</content> </td><td styleCode=\"Toprule Lrule Rrule \">Grade &#x2265;2</td><td styleCode=\"Toprule Lrule Rrule \"><content styleCode=\"underline\">First occurrence</content> <list listType=\"unordered\" styleCode=\"Disc\"><item>Withhold EMRELIS until recovery to Grade &#x2264;1. </item><item>Resume EMRELIS at the same dose level.</item></list><content styleCode=\"underline\">Subsequent occurrence</content><list listType=\"unordered\" styleCode=\"Disc\"><item>Withhold EMRELIS until recovery to Grade &#x2264;1. </item><item>Resume EMRELIS at the next lower dose level. </item></list></td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Other  Adverse Reactions <content styleCode=\"italics\">[see Adverse Reactions (</content><content styleCode=\"italics\"><linkHtml href=\"#_6_1__Clinical\">6.1</linkHtml></content><content styleCode=\"italics\">)]</content> </td><td styleCode=\"Toprule Lrule Rrule \">Grade 3</td><td styleCode=\"Toprule Lrule Rrule \"><content styleCode=\"underline\">First occurrence</content> <list listType=\"unordered\" styleCode=\"Disc\"><item>Withhold EMRELIS until recovery to Grade &#x2264;1. </item><item>Resume EMRELIS at the same dose.</item></list><content styleCode=\"underline\">Subsequent occurrence</content><list listType=\"unordered\" styleCode=\"Disc\"><item>Withhold EMRELIS until recovery to Grade &#x2264;1. </item><item>Resume EMRELIS at the next lower dose level.</item></list></td></tr><tr><td styleCode=\"Lrule Rrule \"/><td styleCode=\"Toprule Lrule Rrule \">Grade 4</td><td styleCode=\"Toprule Lrule Rrule \"><list listType=\"unordered\" styleCode=\"Disc\"><item>Permanently discontinue EMRELIS.</item></list></td></tr><tr><td styleCode=\"Toprule Lrule Rrule \" colspan=\"3\"><sup>a</sup>Adverse reactions were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03</td></tr></tbody></table>","<table><caption>Table 3: Recommended Premedications for Patients Who Experience Infusion-Related Reactions</caption><col width=\"120\"/><col width=\"162\"/><col width=\"132\"/><col width=\"132\"/><col width=\"174\"/><tbody><tr><td styleCode=\"Toprule Lrule Rrule \"><content styleCode=\"bold\">Medication Class</content></td><td styleCode=\"Toprule Lrule Rrule \"><content styleCode=\"bold\">E</content><content styleCode=\"bold\">xamples or equivalent</content></td><td styleCode=\"Toprule Lrule Rrule \"><content styleCode=\"bold\">Dose</content></td><td styleCode=\"Toprule Lrule Rrule \"><content styleCode=\"bold\">Route of Administration</content></td><td styleCode=\"Toprule Lrule Rrule \"><content styleCode=\"bold\">Dosing Window Prior to </content><content styleCode=\"bold\">EMRELIS</content><content styleCode=\"bold\"> Administration</content></td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">H1 Antihistamine</td><td styleCode=\"Toprule Lrule Rrule \">Diphenhydramine</td><td styleCode=\"Toprule Lrule Rrule \">25 to 50 mg</td><td styleCode=\"Toprule Lrule Rrule \">Intravenously or orally</td><td styleCode=\"Toprule Lrule Rrule \">Administer 30-60 minutes prior to each infusion</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">H2 Antihistamine</td><td styleCode=\"Toprule Lrule Rrule \">Famotidine</td><td styleCode=\"Toprule Lrule Rrule \">20 mg</td><td styleCode=\"Toprule Lrule Rrule \">Intravenously or orally </td><td styleCode=\"Toprule Lrule Rrule \">Administer 30-60 minutes prior to each infusion</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Antipyretic</td><td styleCode=\"Toprule Lrule Rrule \">Acetaminophen</td><td styleCode=\"Toprule Lrule Rrule \">650 to 1,000 mg</td><td styleCode=\"Toprule Lrule Rrule \">Intravenously or orally</td><td styleCode=\"Toprule Lrule Rrule \">Administer 30-60 minutes prior to each infusion</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">Glucocorticoid</td><td styleCode=\"Toprule Lrule Rrule \">Methylprednisolone </td><td styleCode=\"Toprule Lrule Rrule \">125 mg or equivalent</td><td styleCode=\"Toprule Lrule Rrule \">Intravenously</td><td styleCode=\"Toprule Lrule Rrule \">Administer 30-60 minutes prior to each infusion</td></tr></tbody></table>","<table><caption>Table 4. Reconstitution Volumes</caption><col width=\"132\"/><col width=\"306\"/><tbody><tr><td styleCode=\"Toprule Lrule Rrule \"><content styleCode=\"bold\">Dose Vial</content></td><td styleCode=\"Toprule Lrule Rrule \"><content styleCode=\"bold\">Volume of Sterile Water for Injection required for reconstitution</content></td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">20 mg vial</td><td styleCode=\"Toprule Lrule Rrule \" valign=\"bottom\">1.1 mL</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">100 mg vial</td><td styleCode=\"Toprule Lrule Rrule \" valign=\"bottom\">5.2 mL</td></tr></tbody></table>"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 0074-1044-01 Emrelis™ (telisotuzumab vedotin-tllv) For Injection 20 mg per vial Hazardous Drug For Intravenous Infusion after reconstitution and dilution Single-Dose Vial Discard Unused Portion Dispense the enclosed Medication Guide to each patient Rx Only abbvie PRINCIPAL DISPLAY PANEL NDC 0074-1044-01 Emrelis™ (telisotuzumab vedotin-tllv) For Injection 20 mg per vial Hazardous Drug For Intravenous Infusion after reconstitution and dilution Single-Dose Vial Discard Unused Portion Dispense the enclosed Medication Guide to each patient Rx Only abbvie","PRINCIPAL DISPLAY PANEL NDC 0074-1055-01 Emrelis™ (telisotuzumab vedotin-tllv) For Injection 100 mg per vial Hazardous Drug For Intravenous Infusion after reconstitution and dilution Single-Dose Vial Discard Unused Portion Dispense the enclosed Medication Guide to each patient Rx Only abbvie PRINCIPAL DISPLAY PANEL NDC 0074-1055-01 Emrelis™ (telisotuzumab vedotin-tllv) For Injection 100 mg per vial Hazardous Drug For Intravenous Infusion after reconstitution and dilution Single-Dose Vial Discard Unused Portion Dispense the enclosed Medication Guide to each patient Rx Only abbvie"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies in animals have not been performed with telisotuzumab vedotin-tllv or the small molecule MMAE. Mutagenesis MMAE was positive for genotoxicity in the in vivo rat bone marrow micronucleus study through an aneugenic mechanism. MMAE was not mutagenic in the bacterial reverse mutation (Ames) assay or the L5178Y TK +/- mouse lymphoma forward mutation assay. Impairment of Fertility Fertility studies with telisotuzumab vedotin-tllv or MMAE have not been conducted. However, results of repeat-dose toxicity studies in rats and monkeys indicate the potential for telisotuzumab vedotin-tllv to impair male and female reproductive function and fertility. In a 2-week repeat-dose toxicology study in rats, telisotuzumab vedotin-tllv administered at doses ≥6 mg/kg (≥12 times the human exposure [AUC] at the recommended dose) resulted in decreased number/degeneration of germ cells in the testes largely due to loss of spermatogonia. The reversibility of these findings was not assessed. In a 4-week repeat-dose toxicology study in sexually immature monkeys, telisotuzumab vedotin-tllv administered at doses ≥3 mg/kg (≥4 times the human exposure [AUC] at the recommended dose) resulted in degeneration of granulosa cells and decreased number of tertiary follicles in the ovaries and degeneration/necrosis of endometrial glands in the uterus. There was evidence of reversibility after an 8-week recovery period."]},"tags":[{"label":"Monoclonal Antibody","category":"modality"},{"label":"Intravenous","category":"route"},{"label":"Vial","category":"form"},{"label":"Active","category":"status"},{"label":"non-small cell lung cancer (NSCLC) with high c-Met protein overexpression","category":"indication"},{"label":"locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression","category":"indication"},{"label":"Abbvie Inc","category":"company"},{"label":"Approved 2020s","category":"decade"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"PNEUMONIA","source":"FDA FAERS","actionTaken":"4 reports"},{"date":"","signal":"KERATITIS","source":"FDA FAERS","actionTaken":"3 reports"},{"date":"","signal":"INTERSTITIAL LUNG DISEASE","source":"FDA FAERS","actionTaken":"2 reports"},{"date":"","signal":"NEUROPATHY PERIPHERAL","source":"FDA FAERS","actionTaken":"2 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"2 reports"},{"date":"","signal":"PNEUMONITIS","source":"FDA FAERS","actionTaken":"2 reports"},{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"2 reports"},{"date":"","signal":"VISION BLURRED","source":"FDA FAERS","actionTaken":"2 reports"},{"date":"","signal":"AGRANULOCYTOSIS","source":"FDA FAERS","actionTaken":"1 reports"},{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"1 reports"}],"drugInteractions":[{"url":"/drug/strong-cyp3a-inhibitors","drug":"Strong CYP3A Inhibitors","action":"Monitor","effect":"may increase the AUC of MMAE","source":"OpenFDA Label","drugSlug":"strong-cyp3a-inhibitors"},{"url":"/drug/strong-cyp3a-inhibitors","drug":"Strong CYP3A Inhibitors","action":"Monitor","effect":"may increase unconjugated MMAE AUC","source":"OpenFDA Label","drugSlug":"strong-cyp3a-inhibitors"}],"commonSideEffects":[{"effect":"Peripheral neuropathy","drugRate":"51%","severity":"serious","_validated":true},{"effect":"Fatigue","drugRate":"29%","severity":"common","_validated":true},{"effect":"Peripheral edema","drugRate":"22%","severity":"common","_validated":true},{"effect":"Decreased appetite","drugRate":"22%","severity":"common","_validated":true},{"effect":"ILD/pneumonitis","drugRate":"10%","severity":"common","_validated":true},{"effect":"Pneumonia","drugRate":"6%","severity":"common","_validated":true},{"effect":"Nausea","drugRate":"15%","severity":"common","_validated":true},{"effect":"Constipation","drugRate":"0.6%","severity":"mild","_validated":true},{"effect":"Vomiting","drugRate":"0.6%","severity":"mild","_validated":true},{"effect":"Blurred vision","drugRate":"15%","severity":"common","_validated":true},{"effect":"Keratitis","drugRate":"11%","severity":"common","_validated":true},{"effect":"Glucose increased","drugRate":"58%","severity":"serious","_validated":true},{"effect":"Calcium decreased","drugRate":"47%","severity":"serious","_validated":true},{"effect":"Alanine transaminase increased","drugRate":"41%","severity":"serious","_validated":true},{"effect":"Gamma glutamyl transferase increased","drugRate":"36%","severity":"serious","_validated":true},{"effect":"Phosphorus decreased","drugRate":"33%","severity":"serious","_validated":true},{"effect":"Sodium decreased","drugRate":"30%","severity":"serious","_validated":true},{"effect":"Lymphocytes decreased","drugRate":"37%","severity":"serious","_validated":true},{"effect":"Hemoglobin decreased","drugRate":"35%","severity":"serious","_validated":true},{"effect":"Pleural effusion","drugRate":"2.4%","severity":"serious","_validated":true},{"effect":"Arthralgia","drugRate":"reported","severity":"unknown"},{"effect":"Dizziness","drugRate":"reported","severity":"unknown"},{"effect":"Dry eye","drugRate":"reported","severity":"unknown"},{"effect":"Infusion-related reaction","drugRate":"reported","severity":"unknown"},{"effect":"Photophobia","drugRate":"reported","severity":"unknown"}],"contraindications":[],"specialPopulations":{"Pregnancy":"Avoid use in pregnancy. EMRELIS can cause fetal harm when administered to a pregnant woman. There are no available human data on EMRELIS use in pregnant women to inform a drug-associated risk. In an animal reproduction study, administration of the small molecule component of EMRELIS, MMAE, to pregnant rats during organogenesis resulted in embryo-fetal mortality and structural abnormalities at exposures similar to the clinical exposure at the recommended dose. Advise patients of the potential risks to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.","Geriatric use":"Of the 168 patients with previously treated EGFR wild-type non-squamous NSCLC with c-Met protein overexpression treated with EMRELIS in LUMINOSITY, 50% were ≥65 years of age and 12% were ≥75 years of age. No overall differences in safety or effectiveness were observed between older and younger patients.","Paediatric use":"Safety and effectiveness of EMRELIS have not been established in pediatric patients.","Hepatic impairment":"Avoid use of EMRELIS."}},"trials":[],"aliases":[],"company":"Abbvie Inc","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=TELISOTUZUMAB","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:49:47.404672+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:49:53.098394+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:49:44.873990+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=TELISOTUZUMAB","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:49:53.605399+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:49:44.425023+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:49:44.425057+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T00:49:55.067864+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Hepatocyte growth factor receptor inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:49:54.655906+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3545419/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:49:54.309602+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"BLA761384","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:49:44.425062+00:00"}},"allNames":"emrelis","offLabel":[],"synonyms":["Emrelis","TELISOTUZUMAB VEDOTIN"],"timeline":[{"date":"20250514","type":"positive","source":"OpenFDA","milestone":"FDA approval (Abbvie Inc)"}],"approvals":[{"date":"20250514","orphan":false,"company":"ABBVIE INC","regulator":"FDA"}],"brandName":"Emrelis","ecosystem":[],"mechanism":{"modality":"Monoclonal Antibody","explanation":"Telisotuzumab vedotin-tllv is a c-Met-directed antibody drug conjugate (ADC). The antibody is a humanized IgG1κ directed against c-Met, the cell surface receptor for hepatocyte growth factor. The small molecule, MMAE, is a microtubule-disrupting agent, attached to the antibody via a protease cleavable linker. Following binding to c-Met-expressing cells, telisotuzumab vedotin-tllv undergoes internalization and intracellular cleavage of MMAE. MMAE disrupts the microtubule network of actively dividing cells, subsequently inducing cell cycle arrest and apoptotic cell death. Telisotuzumab vedotin-tllv exhibited antitumor activity in xenograft models of NSCLC.","oneSentence":"Emrelis binds to the c-Met protein on cancer cells, blocking its growth-promoting signals.","technicalDetail":"Emrelis is a monoclonal antibody that targets the hepatocyte growth factor receptor (c-Met) through a high-affinity interaction, thereby inhibiting the receptor's autophosphorylation and downstream signaling pathways, which are crucial for tumor growth and metastasis."},"commercial":{"launchDate":"2025","_launchSource":"OpenFDA (20250514, ABBVIE INC)"},"references":[{"id":1,"url":"https://api.fda.gov/drug/label.json?search=openfda.generic_name:\"TELISOTUZUMAB\"","fields":["mechanism","indications","adverse_reactions","contraindications","warnings","dosage"],"source":"OpenFDA Label"},{"id":2,"url":"https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:\"TELISOTUZUMAB\"","fields":["approvals","company"],"source":"OpenFDA Drugs@FDA"},{"id":3,"url":"https://clinicaltrials.gov/search?intr=telisotuzumab","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":4,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=telisotuzumab","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-31T10:37:15.222823","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:49:57.905048+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[],"genericName":"telisotuzumab","indications":{"approved":[{"name":"non-small cell lung cancer (NSCLC) with high c-Met protein overexpression","source":"OpenFDA Label","regulator":"FDA"},{"name":"locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression","source":"OpenFDA Label","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06628310","phase":"PHASE2","title":"A Study to Evaluate the Adverse Events, Efficacy, and Optimal Dose of Intravenous (IV) ABBV-400 in Combination With IV Fluorouracil, Leucovorin, and Budigalimab in Adult Participants With Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma","status":"RECRUITING","sponsor":"AbbVie","startDate":"2024-12-13","conditions":["Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma","Esophageal Adenocarcinoma"],"enrollment":180,"completionDate":"2030-10"},{"nctId":"NCT06820463","phase":"PHASE2","title":"A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer","status":"RECRUITING","sponsor":"AbbVie","startDate":"2025-04-24","conditions":["Metastatic Colorectal Cancer"],"enrollment":390,"completionDate":"2028-04"},{"nctId":"NCT07490301","phase":"PHASE2,PHASE3","title":"A Study to Assess Intravenous (IV) Telisotuzumab Adizutecan in Combination With Fluorouracil, Folinic Acid, and Oxaliplatin (FOLFOX) Compared to Standard of Care in Adult Participants With First-Line Metastatic Pancreatic Ductal Adenocarcinoma","status":"NOT_YET_RECRUITING","sponsor":"AbbVie","startDate":"2026-06-03","conditions":["Metastatic Pancreatic Ductal Adenocarcinoma","PDAC"],"enrollment":900,"completionDate":"2031-06"},{"nctId":"NCT07005102","phase":"PHASE2,PHASE3","title":"A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer","status":"RECRUITING","sponsor":"AbbVie","startDate":"2025-08-03","conditions":["Non-Squamous Non-Small Cell Lung Cancer"],"enrollment":854,"completionDate":"2036-11"},{"nctId":"NCT04928846","phase":"PHASE3","title":"A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)","status":"RECRUITING","sponsor":"AbbVie","startDate":"2022-03-25","conditions":["Non Small Cell Lung Cancer"],"enrollment":698,"completionDate":"2028-03"},{"nctId":"NCT07023289","phase":"PHASE2","title":"A Study to Assess Adverse Events and Change in Disease Activity in Adult Participants Receiving Intravenously Infused Telisotuzumab Adizutecan Alone or With Standard of Care in Participants With Post Adjuvant Circulating Tumor DNA Positive Colorectal Cancer and No Radiographic Evidence of Disease","status":"RECRUITING","sponsor":"AbbVie","startDate":"2025-08-07","conditions":["Colorectal Cancer"],"enrollment":140,"completionDate":"2029-11"},{"nctId":"NCT07155187","phase":"PHASE2,PHASE3","title":"A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer","status":"RECRUITING","sponsor":"AbbVie","startDate":"2025-12-10","conditions":["Non-Small Cell Lung Cancer"],"enrollment":430,"completionDate":"2030-09"},{"nctId":"NCT07196644","phase":"PHASE2","title":"A Study to Assess Adverse Events and Change in Disease Activity in Participants 12 Years of Age or Older With Locally Advanced or Metastatic Solid Tumors That Harbor MET Amplification Receiving Intravenously Infused Telisotuzumab Adizutecan","status":"RECRUITING","sponsor":"AbbVie","startDate":"2025-10-29","conditions":["Solid Tumors Harboring MET Amplification"],"enrollment":125,"completionDate":"2030-12"},{"nctId":"NCT06772623","phase":"PHASE1,PHASE2","title":"Study to Evaluate Adverse Events and Efficacy of Intravenous (IV) Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations","status":"RECRUITING","sponsor":"AbbVie","startDate":"2025-03-06","conditions":["Non Small Cell Lung Carcinoma"],"enrollment":252,"completionDate":"2027-11"},{"nctId":"NCT06568939","phase":"PHASE2","title":"A Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Vedotin (ABBV-399) Moves Through the Body as a Monotherapy in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)","status":"RECRUITING","sponsor":"AbbVie","startDate":"2025-01-20","conditions":["Non-Small Cell Lung Cancer"],"enrollment":150,"completionDate":"2028-02"},{"nctId":"NCT04830202","phase":"","title":"Expanded Access to Telisotuzumab Vedotin","status":"AVAILABLE","sponsor":"AbbVie","startDate":"","conditions":["Non-Small Cell Lung Cancer (NSCLC)"],"enrollment":0,"completionDate":""},{"nctId":"NCT05982873","phase":"","title":"Expanded Access to Telisotuzumab Adizutecan","status":"AVAILABLE","sponsor":"AbbVie","startDate":"","conditions":["Solid Tumors"],"enrollment":0,"completionDate":""},{"nctId":"NCT07323641","phase":"PHASE2","title":"Telisotuzumab Vedotin and Osimertinib for the Treatment of Progressive, Incurable, Non Small Cell Lung Cancer","status":"NOT_YET_RECRUITING","sponsor":"Jonsson Comprehensive Cancer Center","startDate":"2026-02-01","conditions":["Lung Non-Small Cell Carcinoma"],"enrollment":60,"completionDate":"2028-02-01"},{"nctId":"NCT03539536","phase":"PHASE2","title":"Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"AbbVie","isPivotal":true,"startDate":"2018-10-10","conditions":["Non-small Cell Lung Cancer"],"enrollment":270,"completionDate":"2026-08"},{"nctId":"NCT05513703","phase":"PHASE2","title":"A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants With Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)","status":"TERMINATED","sponsor":"AbbVie","startDate":"2022-11-21","conditions":["Non Small Cell Lung Cancer"],"enrollment":9,"completionDate":"2024-10-28"},{"nctId":"NCT06614192","phase":"PHASE3","title":"A Study Assessing Adverse Events and Disease Activity When Comparing Intravenously (IV) Infused ABBV-400 to Trifluridine and Tipiracil (LONSURF) Oral Tablets Plus IV Infused Bevacizumab in Adult Participants With c-Met Protein Above Cutoff Level Above Refractory Metastatic Colorectal Cancer","status":"RECRUITING","sponsor":"AbbVie","startDate":"2024-11-08","conditions":["Metastatic Colorectal Cancer"],"enrollment":460,"completionDate":"2028-10"},{"nctId":"NCT02099058","phase":"PHASE1","title":"A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors","status":"ACTIVE_NOT_RECRUITING","sponsor":"AbbVie","startDate":"2014-01-15","conditions":["Advanced Solid Tumors Cancer"],"enrollment":237,"completionDate":"2026-08"},{"nctId":"NCT06464692","phase":"PHASE1,PHASE2","title":"Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Adizutecan (ABBV-400) Moves Through the Body of Adult Participants With Unresectable Locally Advanced/Metastatic Colorectal Cancer","status":"RECRUITING","sponsor":"AbbVie","startDate":"2024-09-30","conditions":["Colorectal Cancer"],"enrollment":30,"completionDate":"2028-09"},{"nctId":"NCT06068842","phase":"","title":"A Study to Assess Prevalence of a Specific Protein Overexpression in Adult Participants With Non-Small Cell Lung Cancer","status":"COMPLETED","sponsor":"AbbVie","startDate":"2023-11-03","conditions":["Non Small Cell Lung Cancer"],"enrollment":579,"completionDate":"2024-12-31"},{"nctId":"NCT06093503","phase":"PHASE3","title":"Study of Intravenous Telisotuzumab Vedotin in Combination Osimertinib or Standard of Care Chemotherapy to Assess Change in Disease Activity in Adult Participants With Non-Small Cell Lung Cancer That Has a Mutation in the Epidermal Growth Factor Receptor Gene and That Overexpresses the c-Met Protein","status":"WITHDRAWN","sponsor":"AbbVie","startDate":"2024-05-31","conditions":["Non-Small Cell Lung Cancer"],"enrollment":0,"completionDate":"2028-04-11"},{"nctId":"NCT03574753","phase":"PHASE2","title":"Lung-MAP S1400K: c-MET Positive","status":"COMPLETED","sponsor":"SWOG Cancer Research Network","startDate":"2018-03-16","conditions":["Recurrent Squamous Cell Lung Carcinoma","Stage IV Squamous Cell Lung Carcinoma AJCC V7"],"enrollment":28,"completionDate":"2021-07-30"},{"nctId":"NCT03311477","phase":"PHASE1","title":"A Study to Evaluate the Safety and Pharmacokinetics ABBV-399 in Japanese Participants With Solid Tumors","status":"COMPLETED","sponsor":"AbbVie","startDate":"2017-11-06","conditions":["Advanced Solid Tumors Cancer"],"enrollment":9,"completionDate":"2019-03-04"},{"nctId":"NCT01472016","phase":"PHASE1","title":"Study of ABT-700 in Subjects With Advanced Solid Tumors","status":"COMPLETED","sponsor":"AbbVie (prior sponsor, Abbott)","startDate":"2011-10-06","conditions":["Advanced Solid 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Advanced Gastric/Gastroesophageal Junction Cancer.","journal":"Clinical cancer research : an official journal of the American Association for Cancer Research"},{"date":"2026 Jan 30","pmid":"41754785","title":"2025 FDA TIDES (Peptides and Oligonucleotides) Harvest.","journal":"Pharmaceuticals (Basel, Switzerland)"},{"date":"2026 Mar","pmid":"41748495","title":"Population Pharmacokinetics and Exposure-Response Analyses for Telisotuzumab Vedotin in Patients With c-Met Protein Overexpressing Tumors.","journal":"CPT: pharmacometrics & systems pharmacology"},{"date":"2026 Jan 8","pmid":"41595127","title":"Targeting Mesenchymal-Epidermal Transition (MET) Aberrations in Non-Small Cell Lung Cancer: Current Challenges and Therapeutic Advances.","journal":"Cancers"},{"date":"2026 Mar 12","pmid":"41460676","title":"Emrelis: A New Approach in Treating MET-high Locally Advanced or Metastatic Non-squamous NSCLC; A Mini Review.","journal":"Thoracic research and 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