{"id":"deruxtecan","rwe":[{"pmid":"41911866","year":"2026","title":"CLO26-087: Efficacy and Safety of Trastuzumab Deruxtecan in HER2-Positive Gastric Cancer: A Systematic Review and Meta-analysis.","finding":"","journal":"Journal of the National Comprehensive Cancer Network : JNCCN","studyType":"Clinical Study"},{"pmid":"41901620","year":"2026","title":"The Effect of HER3 Expression on Prognosis in EGFR-Mutant Non-Small Cell Lung Cancer: A Retrospective Real-World Study.","finding":"","journal":"Medicina (Kaunas, Lithuania)","studyType":"Clinical Study"},{"pmid":"41899536","year":"2026","title":"Overcoming Trastuzumab-Pertuzumab Resistance and Optimizing Sequential Anti-HER2 Therapy in HER2-Positive Metastatic Breast Cancer.","finding":"","journal":"Cancers","studyType":"Clinical Study"},{"pmid":"41899531","year":"2026","title":"Association Between Single-Nucleotide Polymorphism and Trastuzumab Deruxtecan-Induced Interstitial Lung Disease in Breast Cancer Using the Japonica Array NEO.","finding":"","journal":"Cancers","studyType":"Clinical Study"},{"pmid":"41893011","year":"2026","title":"Next Frontier in HER2+/HR+ Breast Cancer: Leveraging Cell Cycle Control with CDK4/6 Inhibitors.","finding":"","journal":"Journal of personalized medicine","studyType":"Clinical Study"}],"_fda":{"id":"b4f34665-c131-4e90-b928-1acc733b7aa0","set_id":"2950227c-6230-4ca4-a135-46e44d9424a0","openfda":{"unii":["GD2OWY1DTK"],"route":["INTRAVENOUS"],"rxcui":["2703040","2703046"],"spl_id":["b4f34665-c131-4e90-b928-1acc733b7aa0"],"brand_name":["DATROWAY"],"spl_set_id":["2950227c-6230-4ca4-a135-46e44d9424a0"],"package_ndc":["65597-801-01"],"product_ndc":["65597-801"],"generic_name":["DATOPOTAMAB DERUXTECAN"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["DATOPOTAMAB DERUXTECAN"],"manufacturer_name":["Daiichi Sankyo Inc."],"application_number":["BLA761394"],"is_original_packager":[true]},"version":"17","pregnancy":["8.1 Pregnancy Risk Summary Based on its mechanism of action, DATROWAY can cause embryo-fetal harm when administered to a pregnant woman because the topoisomerase inhibitor component of DATROWAY, DXd, is genotoxic and affects actively dividing cells [see Clinical Pharmacology (12.1) , Nonclinical Toxicology (13.1) ] . There are no available data on the use of DATROWAY in pregnant women to inform a drug-associated risk. 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 There were no animal reproductive or developmental toxicity studies conducted with datopotamab deruxtecan-dlnk."],"references":["15 REFERENCES OSHA Hazardous Drugs. OSHA . http://www.osha.gov/SLTC/hazardousdrugs/index.html"],"description":["11 DESCRIPTION Datopotamab deruxtecan-dlnk is a Trop-2-directed antibody and topoisomerase inhibitor conjugate. Datopotamab deruxtecan-dlnk is an antibody-drug conjugate (ADC) composed of three components: 1) a humanized anti-Trop-2 IgG1 monoclonal antibody (mAb), covalently linked to 2) a topoisomerase I inhibitor, via 3) a tetrapeptide-based cleavable linker. Deruxtecan is composed of a protease-cleavable maleimide tetrapeptide linker and the topoisomerase inhibitor, DXd, which is an exatecan derivative. The antibody is produced in Chinese hamster ovary cells by recombinant DNA technology, and the topoisomerase inhibitor and linker are produced by chemical synthesis. Approximately 4 molecules of deruxtecan are attached to each antibody molecule. Datopotamab deruxtecan-dlnk has the following structure: DATROWAY (datopotamab deruxtecan-dlnk) for injection is a sterile, white to yellowish white, preservative-free lyophilized powder in single-dose vials. Each vial delivers 100 mg of datopotamab deruxtecan-dlnk, L-histidine (3.88 mg), L-histidine hydrochloride monohydrate (5.25 mg), polysorbate 80 (1.50 mg), and sucrose (450 mg). Following reconstitution with 5 mL of Sterile Water for Injection, USP, the resulting concentration of datopotamab deruxtecan-dlnk is 20 mg/mL with a pH of 6.0. The resulting solution is administered by intravenous infusion following dilution. Chemical Structure"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied DATROWAY (datopotamab deruxtecan-dlnk) for injection is a white to yellowish white lyophilized powder supplied as: Carton Contents NDC One 100 mg single-dose vial NDC 65597-801-01 Storage and Handling Store vials in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF) in the original carton to protect from light until time of reconstitution. Do not freeze. Do not shake the reconstituted or diluted solution [see Dosage and Administration (2.5) ] . DATROWAY (datopotamab deruxtecan-dlnk) is a hazardous drug. Follow applicable special handling and disposal procedures. 1"],"spl_medguide":["This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 06/2025 MEDICATION GUIDE DATROWAY ® (DAT-roe-way) (datopotamab deruxtecan-dlnk) for injection, for intravenous use What is the most important information I should know about DATROWAY? DATROWAY can cause serious side effects, including: Lung problems that may be severe, life-threatening, or that may lead to death . If you develop lung problems your healthcare provider may treat you with corticosteroid medicines. Tell your healthcare provider right away if you get any of the following signs and symptoms: cough trouble breathing or shortness of breath fever other new or worsening breathing symptoms such as chest tightness or wheezing Eye problems. Eye problems are common with DATROWAY and can also be severe. Tell your healthcare provider right away if you develop any new or worsening eye problems during treatment with DATROWAY, including dry eyes, eye pain, eye redness, eye swelling, eye irritation, increased tears, feeling like something is in your eyes, discharge from your eyes, eye crusting, sensitivity to light, blurred vision, or vision changes. You should use preservative-free lubricating eye drops at least 4 times a day and as needed. Do not wear contact lenses during treatment with DATROWAY unless your eye specialist tells you to. Your healthcare provider will send you to an eye specialist to check your eyes when you start your treatment with DATROWAY, every year during treatment, at the end of treatment, and as needed for any new or worsening signs and symptoms of eye problems. Mouth ulcers and sores. Mouth ulcers and sores are common with DATROWAY and can also be severe. Tell your healthcare provider right away if you develop mouth pain, swelling, redness, ulcers, or sores during treatment with DATROWAY. Your healthcare provider will prescribe a steroid-containing mouthwash to use 4 times a day and as needed during treatment with DATROWAY. You should hold ice chips or ice water in your mouth during your DATROWAY infusions. Your healthcare provider will check you for these side effects during your treatment with DATROWAY. Your healthcare provider may reduce your dose, delay treatment, or completely stop treatment with DATROWAY if you have severe side effects. Harm to your unborn baby. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with DATROWAY. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with DATROWAY. Females who are able to become pregnant should use effective birth control (contraception) during treatment with DATROWAY and for 7 months after the last dose. Males who have female partners that are able to become pregnant should use effective birth control (contraception) during treatment with DATROWAY and for 4 months after the last dose. See \" What are the possible side effects of DATROWAY? \" for more information about side effects. What is DATROWAY? DATROWAY is a prescription medicine used to treat adults who have: non-small cell lung cancer (NSCLC) that has certain mutations in a gene called epidermal growth factor receptor (EGFR): that has spread to areas outside of the lung (locally advanced) or has spread to other parts of the body (metastatic), and who have received prior EGFR-directed medicine and platinum-based chemotherapy. hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer: that cannot be removed by surgery (unresectable) or has spread to other parts of the body (metastatic), and who have received prior endocrine-based therapy and chemotherapy treatment for unresectable or metastatic disease. It is not known if DATROWAY is safe and effective in children. Before receiving DATROWAY, tell your healthcare provider about all of your medical conditions, including if you: have lung or breathing problems. have eye problems. use contact lenses. are breastfeeding or plan to breastfeed. It is not known if DATROWAY passes into your breast milk. Do not breastfeed during treatment with DATROWAY 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. How will I receive DATROWAY? You will receive DATROWAY into your vein through an intravenous (IV) line by your healthcare provider. DATROWAY is usually given 1 time every three weeks (21-day treatment cycle). You will receive your first infusion over 90 minutes. If you do not have problems with your first infusion, you may receive your next infusions over 30 minutes. You will be monitored for side effects for at least 1 hour after your first 2 infusions. If you do not have problems after your second infusion, you will be monitored for at least 30 minutes after each following infusion. Your healthcare provider will decide how many treatments you need. Your healthcare provider will give you medicines before your infusion to help prevent nausea, vomiting, and infusion-related reactions. Your healthcare provider may slow down or temporarily stop your infusion of DATROWAY if you have an infusion-related reaction, or permanently stop DATROWAY if you have severe infusion reactions. If you miss a planned dose of DATROWAY, call your healthcare provider right away to schedule an appointment. Do not wait until the next planned treatment cycle. What are the possible side effects of DATROWAY? DATROWAY can cause serious side effects, including: See \" What is the most important information I should know about DATROWAY? \" The most common side effects of DATROWAY when used in adults with EGFR-mutated non-small cell lung cancer include: nausea hair loss tiredness decreased red blood cell counts decreased white blood cell counts constipation increased blood levels of calcium increased blood levels of liver enzymes increased levels of enzyme called lactate dehydrogenase in the blood muscle and joint pain rash decreased appetite The most common side effects of DATROWAY when used in adults with HR-positive HER2-negative breast cancer include: nausea tiredness decreased white blood cell counts decreased blood levels of calcium hair loss decreased red blood cell counts constipation dry eye vomiting increased blood levels of liver enzymes an eye problem called keratitis. See \" What is the most important information I should know about DATROWAY? \" increased blood levels of alkaline phosphatase DATROWAY may cause fertility problems in males and females, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility. These are not all of the possible side effects of DATROWAY. 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 DATROWAY. 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 DATROWAY that is written for health professionals. What are the ingredients in DATROWAY? Active ingredient: datopotamab deruxtecan-dlnk Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, and sucrose Manufactured by: Daiichi Sankyo, Inc., Basking Ridge, NJ 07920 U.S. License No. 2128 Marketed by : Daiichi Sankyo, Inc., Basking Ridge, NJ 07920 and AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 DATROWAY ® is a registered trademark of Daiichi Sankyo Company, Ltd. © 2025 Daiichi Sankyo Co., Ltd. USMG-DAT-C7-0625-r002 For more information, call 1-877-437-7763 or go to https://www.DATROWAY.com."],"geriatric_use":["8.5 Geriatric Use Of the 125 patients with EGFR-mutated NSCLC in TROPION-Lung05, TROPION-Lung01, TROPION-PanTumor01 treated with DATROWAY 6 mg/kg, 44% were ≥65 years of age and 10% were ≥75 years of age. No clinically meaningful differences in efficacy and safety were observed between patients ≥65 years of age versus younger patients. Of the 365 patients in TROPION-Breast01 treated with DATROWAY 6 mg/kg, 25% were ≥65 years of age and 5% were ≥75 years of age. Grade ≥3 and serious adverse reactions were more common in patients ≥65 years (42% and 25%, respectively) compared to patients <65 years (33% and 15%, respectively). In TROPION-Breast01, no other meaningful differences in safety or efficacy were observed between patients ≥65 years of age versus younger patients."],"pediatric_use":["8.4 Pediatric Use Safety and effectiveness of DATROWAY have not been established in pediatric patients."],"effective_time":"20260320","clinical_studies":["14 CLINICAL STUDIES 14.1 Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer The efficacy of DATROWAY was evaluated in a pooled subgroup of patients with locally advanced or metastatic EGFR-mutated NSCLC who were enrolled across two clinical studies: TROPION-Lung05 and TROPION-Lung01. TROPION-Lung05 (NCT04484142) was a global, multicenter, single-arm, open-label trial in patients with previously treated NSCLC with an actionable genomic alteration and TROPION-Lung01 (NCT04656652) was a global, multicenter, randomized, active-controlled, open-label trial in patients with previously treated NSCLC with or without an actionable genomic alteration. For both trials, eligible patients with EGFR-mutated NSCLC must have previously received an EGFR-directed therapy and platinum-based chemotherapy. Patients with a history of ILD/pneumonitis requiring treatment with steroids, ongoing ILD/pneumonitis, or clinically significant corneal disease at screening were ineligible. Patients who had brain metastases that were untreated and symptomatic were also ineligible. Patients received DATROWAY 6 mg/kg by intravenous infusion every 3 weeks until unacceptable toxicity or disease progression. For the pooled efficacy population, the major efficacy outcome measure was overall response rate (ORR) by BICR per RECIST v1.1. An additional efficacy outcome was duration of response (DOR) by BICR. Efficacy was assessed in 114 patients with EGFR-mutated NSCLC. The median age was 63 years (range 36 to 81); 43% were ≥65 years of age; 63% were female; 70% were Asian and 22% were White; 1.8% were of Hispanic/Latino ethnicity; 68% had ECOG PS of 1 and 32% had ECOG PS of 0; and 33% had brain metastases at baseline. Fifty-three percent (53%) of patients had tumors with exon 19 deletions, 34% had exon 21 L858R mutations, 28% had T790M mutations, 2.6% had exon 20 insertion mutations and 14% had other EGFR mutations. Four percent (4.4%) of patients received one prior line of systemic therapy, 39% received two prior lines of systemic therapy, and 57% received three or more prior lines of systemic therapy in the locally advanced or metastatic setting. All patients received prior EGFR-directed therapy including 84% receiving prior osimertinib; 99% received prior platinum-based chemotherapy and 28% received prior anti-PD-1/ PD-L1 therapy. Efficacy results are summarized in Table 9. Table 9: Efficacy Results in TROPION-Lung05 and TROPION-Lung01 by BICR DATROWAY TL05 N=77 DATROWAY TL01 N=37 DATROWAY Pooled N=114 CI: confidence interval Overall Response Rate (95% CI) 45% (34, 57) 43% (27, 61) 45% (35, 54) Complete Response 5% 2.7% 4.4% Partial Response 40% 41% 40% Duration of Response Median, months (95% CI) 6.9 (4.2, 10.2) 6.5 (4.0, 8.4) 6.5 (4.2, 8.4) ≥6 months 49% 44% 47% ≥12 months 23% 6% 18% In the TROPION-Lung05 trial, a difference was noted between ORR by BICR and ORR assessed by investigator; investigator assessed ORR was 34% (95% CI: 23, 45). In the TROPION-Lung01 trial, ORR assessed by investigator was similar to ORR by BICR. 14.2 Unresectable or Metastatic, HR-Positive, HER2-Negative Breast Cancer TROPION-Breast01 The efficacy of DATROWAY was evaluated in TROPION-Breast01 (NCT05104866), a multicenter, open-label, randomized trial of 732 patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC1+ or IHC2+/ISH-) breast cancer. Eligible patients must have progressed on and deemed not suitable for further endocrine therapy. Patients were required to have received 1 or 2 lines of prior chemotherapy in the unresectable or metastatic disease setting. Patients were excluded for a history of ILD/pneumonitis requiring treatment with steroids, ongoing ILD/pneumonitis, clinically active brain metastases, or clinically significant corneal disease at screening. Patients were also excluded for ECOG performance status >1. Randomization was stratified by previous lines of chemotherapy (one or two), prior treatment with a CDK4/6 inhibitor (yes or no), and geographical region. A total of 732 patients were randomized 1:1 to receive either DATROWAY 6 mg/kg (N=365) by intravenous infusion every 3 weeks or investigator's choice of chemotherapy (N=367) until unacceptable toxicity or disease progression. Single agent chemotherapy was determined by the investigator before randomization from one of the following choices: eribulin (60%), capecitabine (21%), vinorelbine (10%), or gemcitabine (9%). The major efficacy outcomes were progression-free survival (PFS) as assessed by blinded independent central review (BICR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 and overall survival (OS). Additional efficacy outcomes included confirmed objective response rate (ORR) and duration of response (DOR) by BICR. The median age was 55 years (range 28-86); 22% were ≥65 years; 99% were female; 48% were White, 41% were Asian, 1.5% were Black or African American, and 11% were of Hispanic/Latino ethnicity; 57% had ECOG PS of 0 and 42% had ECOG PS of 1; 97% had visceral disease, 72% had liver metastases, and 8% had stable brain metastases. Sixty percent (60%) of patients received prior endocrine therapy in the (neo)adjuvant setting, and 89% received prior endocrine therapy in the unresectable or metastatic setting. Eighty-three percent (83%) of patients had prior treatment with a CDK4/6 inhibitor. All patients received prior chemotherapy regimens in the unresectable or metastatic setting (81% received prior taxanes; 64% received prior anthracyclines). Sixty-two percent (62%) of patients had 1 prior chemotherapy regimen and 38% of patients had 2 prior chemotherapy regimens for treatment of unresectable or metastatic disease. The study demonstrated a statistically significant improvement in PFS in patients randomized to DATROWAY compared to chemotherapy. Efficacy results are shown in Table 10 and Figure 1. Table 10: Efficacy Results in TROPION-Breast01 DATROWAY (n=365) Chemotherapy (n=367) CI: Confidence interval; NS: not statistically significant Progression-Free Survival Assessed by BICR Number of events (%) 212 (58) 235 (64) Progressive Disease 201 (55) 218 (59) Death 11 (3) 17 (5) Median, months (95% CI) 6.9 (5.7, 7.4) 4.9 (4.2, 5.5) Hazard ratio (95% CI) Based on the stratified Cox proportional hazards model 0.63 (0.52, 0.76) p-value Two-sided p-value based on stratified log-rank test. , p-value is compared with the allocated alpha of 0.01. < 0.0001 Overall Survival Number of events (%) 223 (61) 213 (58) Median, months (95% CI) 18.6 (17.3, 20.1) 18.3 (17.3, 20.5) Hazard ratio (95% CI) 1.01 (0.83, 1.22) p-value NS Confirmed Objective Response Rate n (%) 133 (36) 84 (23) (95% CI) 31, 42 19, 28 Complete Response n (%) 2 (0.5) 0 Partial Response n (%) 131 (36) 84 (23) Duration of Response Median, months (95% CI) 6.7 (5.6, 9.8) 5.7 (4.9, 6.8) Figure 1: Kaplan-Meier Plot of PFS by BICR in TROPION-Breast-01 Figure 1"],"pharmacodynamics":["12.2 Pharmacodynamics Datopotamab deruxtecan-dlnk time course of pharmacodynamic response is unknown. Exposure-Response Relationships A relationship between datopotamab deruxtecan-dlnk exposure and efficacy has not been fully characterized in breast cancer or EGFR-mutated NSCLC. In the pooled population of NSCLC (including EGFR-mutated NSCLC) and breast cancer patients, higher datopotamab deruxtecan-dlnk systemic exposure is associated with a higher incidence rate of serious adverse reactions, dosage interruptions, dose reductions, stomatitis/oral mucositis, ocular adverse reactions, and Grade ≥3 adverse reactions. Cardiac Electrophysiology At datopotamab deruxtecan-dlnk doses up to 10 mg/kg (1.7 times the recommended dose), mean increase in the QTc interval >20 ms was not observed."],"pharmacokinetics":["12.3 Pharmacokinetics Datopotamab deruxtecan-dlnk and DXd exposure after the first dose of the approved recommended dosage of cycle 1 are provided in Table 8. Datopotamab deruxtecan-dlnk and released DXd maximum concentration (C max ) and area under the time-concentration curve (AUC) increases proportionally over a dose range of 4 mg/kg to 10 mg/kg (approximately 0.7 to 1.7 times the approved recommended dosage). No clinically significant datopotamab deruxtecan-dlnk accumulation occurs between cycles 1 and 3. Table 8: Datopotamab Deruxtecan-dlnk and DXd Mean (CV%) Exposure After the First Dose PK Parameter Datopotamab deruxtecan-dlnk DXd Abbreviations: C max =maximum concentration; AUC =area under the time-concentration curve C max 154 µg/mL (20%) 2.8 ng/mL (58%) AUC 671 µg*day/mL (31%) 18 ng*day/mL (43%) Distribution Datopotamab deruxtecan-dlnk mean steady state volume of distribution is 3.5 (23%) L. DXd plasma protein binding is approximately 98% and the blood-to-plasma concentration ratio is 0.6 in vitro. Elimination The datopotamab deruxtecan-dlnk median elimination half-life (t 1/2 ) is 4.8 days (1.0, 8.2) and the released DXd median apparent t 1/2 is approximately 5.5 days (3.2, 8.8). The estimated datopotamab deruxtecan-dlnk clearance is 0.6 (31.5%) L/day. Metabolism Datopotamab deruxtecan-dlnk undergoes intracellular cleavage by lysosomal enzymes to release DXd . The humanized Trop-2 IgG1 monoclonal antibody is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG. In vitro, DXd is primarily metabolized by CYP3A4. Specific Populations The mean volume of distribution and clearance of datopotamab deruxtecan-dlnk and DXd increase with increasing body weight (36 kg to 156 kg). No clinically significant differences in the pharmacokinetics of datopotamab deruxtecan-dlnk or DXd were observed based on age (26 to 86 years), race (Asian, White, or Black), sex, mild hepatic impairment (total bilirubin ≤ULN and any AST >ULN or total bilirubin >1 to 1.5 times ULN and any AST), or mild to moderate renal impairment (CLcr 30 to <90 mL/min). The pharmacokinetics of datopotamab deruxtecan-dlnk in patients with moderate hepatic impairment (total bilirubin >1.5 to 3 times ULN and any AST) was comparable to patients with normal hepatic function (total bilirubin and AST ≤ULN). The steady state average DXd AUC was 2.4-fold higher in patients with moderate hepatic impairment compared to patients with normal hepatic function. The effect of severe hepatic impairment (total bilirubin >3 times ULN and any AST) or severe renal impairment (CLcr <30 mL/min) on datopotamab deruxtecan-dlnk or DXd pharmacokinetics is unknown. Drug Interaction Studies Clinical Studies and Model-Informed Approaches No clinically significant differences in DXd pharmacokinetics were predicted when used concomitantly with itraconazole (strong CYP3A inhibitor) or ritonavir (dual OATP1B and CYP3A inhibitor). In Vitro Studies CYP450 Enzymes : DXd does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A and does not induce CYP1A2, CYP2B6, or CYP3A. UDP-Glucuronosyltransferase (UGT): DXd does not undergo significant metabolism by UGT enzymes. Transporters Systems : DXd is a substrate of OATP1B1, OATP1B3, MATE2-K, P-gp, MRP1, and BCRP. DXd does not inhibit OAT1, OAT3, OCT1, OCT2, OATP1B1, OATP1B3, MATE1, MATE2-K, P-gp, BCRP, or BSEP transporters."],"adverse_reactions":["6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Interstitial Lung Disease/Pneumonitis [see Warnings and Precautions (5.1) ] Ocular Adverse Reactions [see Warnings and Precautions (5.2) ] Stomatitis [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥20%), including laboratory abnormalities, in patients with: EGFR-mutated NSCLC were stomatitis, nausea, alopecia, fatigue, decreased hemoglobin, decreased lymphocytes, constipation, increased calcium, increased AST, decreased white blood cell count, increased lactate dehydrogenase, musculoskeletal pain, decreased appetite, increased ALT, and rash. ( 6.1 ) HR-positive, HER2-negative breast cancer were stomatitis, nausea, fatigue, decreased leukocytes, decreased calcium, alopecia, decreased lymphocytes, decreased hemoglobin, constipation, decreased neutrophils, dry eye, vomiting, increased ALT, keratitis, increased AST, and increased alkaline phosphatase. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc. at 1-877-437-7763 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety population described in WARNINGS AND PRECAUTIONS reflects exposure to DATROWAY in 927 patients as a single agent at 6 mg/kg administered as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. This included 137 patients with NSCLC in TROPION-Lung05 [see Clinical Studies (14.1) ] , 297 patients with NSCLC in TROPION-Lung01 [see Clinical Studies (14.1) ] , 360 patients with HR-positive, HER2-negative breast cancer in TROPION-Breast01 [see Clinical Studies (14.2) ] , and 50 patients with NSCLC and 83 patients with breast cancer in TROPION-PanTumor01 (NCT03401385). Among 927 patients who received DATROWAY, 45% were exposed for 6 months or longer and 19% were exposed for greater than one year. In this pooled safety population, the most common (≥20%) adverse reactions were stomatitis (63%), nausea (52%), fatigue (45%), alopecia (38%), constipation (28%), decreased appetite (23%), rash (23%), vomiting (22%), and musculoskeletal pain (20%). In this pooled safety population, the most common (≥2%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes (9%) and decreased hemoglobin (3.5%). Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer TROPION-Lung05, TROPION-Lung01, TROPION-PanTumor01 The safety of DATROWAY was evaluated in 125 patients with EGFR-mutated NSCLC who received DATROWAY 6 mg/kg administered as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity in TROPION-Lung05 and TROPION-Lung01 [see Clinical Studies (14.1) ] as well as TROPION-PanTumor01 (NCT03401385). Among these patients, the median duration of treatment was 6.1 months (range 0.7 months to 41.7 months). The median age was 63 years (range: 36 to 81), 56% of patients were <65 years, 62% of patients were female; 66% were Asian, 26% were White, 0.8% were Black, 6% were other races; and 2.4% were of Hispanic ethnicity. Serious adverse reactions occurred in 26% of patients who received DATROWAY. Serious adverse reactions in >1% of patients who received DATROWAY were COVID-19 (4%), stomatitis (2.4%), and pneumonia (1.6%). Fatal adverse reactions occurred in 1.6% of patients who received DATROWAY, due to death not otherwise specified. Permanent discontinuation of DATROWAY due to an adverse reaction occurred in 8% of patients. Adverse reactions which resulted in permanent discontinuation of DATROWAY in >1% of patients included ILD/pneumonitis (2.4%) and abnormal hepatic function (1.6%). Dosage interruptions of DATROWAY due to an adverse reaction occurred in 43% of patients. Adverse reactions which required dosage interruption in >1% of patients included COVID-19 (13%), stomatitis (7%), fatigue (6%), pneumonia (4%), anemia (2.4%), amylase increased (2.4%), keratitis (2.4%), ILD/pneumonitis (1.6%), decreased appetite (1.6%), dyspnea (1.6%), rash (1.6%), and infusion-related reaction (1.6%). Dose reductions of DATROWAY due to an adverse reaction occurred in 26% of patients. Adverse reactions which required dose reduction in >1% of patients included stomatitis (14%), keratitis (1.6%), fatigue (1.6%), decreased weight (1.6%) and COVID-19 (1.6%). The most common (≥20%) adverse reactions, including laboratory abnormalities, were stomatitis, nausea, alopecia, fatigue, decreased hemoglobin, decreased lymphocytes, constipation, increased calcium, increased AST, decreased white blood cell count, increased lactate dehydrogenase, musculoskeletal pain, decreased appetite, increased ALT, and rash. Table 4: Adverse Reactions (≥10%) in Patients with Locally Advanced or Metastatic EGFR-Mutated NSCLC Who Received DATROWAY in TROPION-Lung05, TROPION-Lung01, and TROPION-PanTumor01 Adverse Reaction DATROWAY N=125 All Grades % Grades 3 or 4 % Events were graded using NCI CTCAE v5.0. Gastrointestinal disorders Stomatitis Includes other related terms 71 9 Nausea 50 0 Constipation 31 0 Vomiting 16 0.8 Diarrhea 12 0 Skin and subcutaneous tissue disorders Alopecia 49 0 Rash 20 0.8 Pruritus 12 0 General disorders and administration site conditions Fatigue Includes fatigue, asthenia, and malaise 42 6 Musculoskeletal and connective tissue disorders Musculoskeletal pain 22 0.8 Metabolism and nutrition disorders Decreased appetite 20 1.6 Infections and Infestations COVID-19 19 2.4 Respiratory, Thoracic, and Mediastinal Disorders Cough 18 0 Dyspnea 11 2.4 Eye disorders Dry eye 13 0 Keratitis Includes corneal disorder, corneal erosion, keratitis, punctate keratitis, and ulcerative keratitis 12 2.4 Injury, poisoning and procedural complications Infusion-related reaction 13 0 Nervous system disorders Headache 13 0 Clinically relevant adverse reactions occurring in <10% of patients who received DATROWAY included dry skin, blurred vision, abdominal pain, conjunctivitis, dry mouth, ILD/pneumonitis, skin hyperpigmentation, increased lacrimation, and visual impairment. Table 5: Select Laboratory Abnormalities (≥20%) that Worsened from Baseline in Patients with Locally Advanced or Metastatic EGFR-Mutated NSCLC Who Received DATROWAY in TROPION-Lung05, TROPION-Lung01, and TROPION-PanTumor01 Laboratory Abnormality Frequencies were based on NCI CTCAE v5.0 grade-derived laboratory abnormalities. DATROWAY The denominator used to calculate the rate varied from 115 to 124 based on the number of patients with a baseline value and at least one post-treatment value. All Grades % Grades 3 or 4 % Hematology Decreased hemoglobin 34 4.8 Decreased lymphocytes 32 11 Decreased white blood cell count 27 1.6 Chemistry Increased calcium 31 0 Increased AST 28 2.4 Increased lactate dehydrogenase 23 0 Increased ALT 20 2.4 Unresectable or Metastatic, HR-Positive, HER2-Negative Breast Cancer TROPION-Breast01 The safety of DATROWAY was evaluated in 360 patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC1+ or IHC2+/ISH-) breast cancer who received at least one dose of DATROWAY 6 mg/kg in TROPION-Breast01 [see Clinical Studies (14.2) ] . DATROWAY was administered by intravenous infusion once every three weeks. The median duration of treatment was 6.7 months (range: 0.7 months to 16.1 months) for patients who received DATROWAY. Serious adverse reactions occurred in 15% of patients who received DATROWAY. Serious adverse reactions in >0.5% of patients who received DATROWAY were urinary tract infection (1.9%), COVID-19 infection (1.7%), ILD/pneumonitis (1.1%), acute kidney injury, pulmonary embolism, vomiting, diarrhea, hemiparesis, and anemia (0.6% each). Fatal adverse reactions occurred in 0.3% of patients who received DATROWAY and were due to ILD/pneumonitis. Permanent discontinuation of DATROWAY due to an adverse reaction occurred in 3.1% of patients. Adverse reactions which resulted in permanent discontinuation of DATROWAY in >0.5% of patients included ILD/pneumonitis (1.7%) and fatigue (0.6%). Dosage interruptions of DATROWAY due to an adverse reaction occurred in 22% of patients. Adverse reactions which required dosage interruption in >1% of patients included COVID-19 (3.3%), infusion-related reaction (1.4%), ILD/pneumonitis (1.9%), stomatitis (1.9%), fatigue (1.7%), keratitis (1.4%), acute kidney injury (1.1%), and pneumonia (1.1%). Dose reductions of DATROWAY due to an adverse reaction occurred in 23% of patients. Adverse reactions which required dose reduction in >1% of patients included stomatitis (13%), fatigue (3.1%), nausea (2.5%), and weight decrease (1.9%). The most common (≥20%) adverse reactions, including laboratory abnormalities, were stomatitis, nausea, fatigue, decreased leukocytes, decreased calcium, alopecia, decreased lymphocytes, decreased hemoglobin, constipation, decreased neutrophils, dry eye, vomiting, increased ALT, keratitis, increased AST, and increased alkaline phosphatase. Table 6: Adverse Reactions (≥10%) in Patients Who Received DATROWAY in TROPION-Breast01 Adverse Reactions DATROWAY N=360 Chemotherapy N=351 All Grades % Grades 3 or 4 % All Grades % Grades 3 or 4 % Events were graded using NCI CTCAE v5.0. Gastrointestinal Disorders Stomatitis Includes other related terms. 59 7 17 2.6 Nausea 56 1.4 27 0.6 Constipation 34 0.3 17 0 Vomiting 24 1.1 12 1.1 Diarrhea 11 0.6 19 1.4 Abdominal pain 11 0.6 15 1.4 General Disorders and Administration Site Conditions Fatigue Includes fatigue, asthenia, lethargy, malaise 44 4.2 40 3.7 Skin and Subcutaneous Tissue Disorders Alopecia 38 0 22 0 Rash 19 0 17 2.3 Eye Disorders Dry eye 27 0.8 13 0 Keratitis Includes corneal disorder, corneal erosion, corneal infiltrates, corneal lesion, corneal toxicity, injury corneal, keratitis, keratopathy, punctate keratitis, and ulcerative keratitis 24 1.1 10 0 Metabolism and Nutrition Disorders Decreased appetite 16 1.4 16 0.9 Infections and Infestations COVID-19 16 1.4 13 0.9 Respiratory, Thoracic, and Mediastinal Disorders Cough 15 0 10 0 Clinically relevant adverse reactions occurring in <10% of patients who received DATROWAY included infusion-related reactions (including bronchospasm), ILD/pneumonitis, headache, pruritus, dry skin, dry mouth, conjunctivitis, blepharitis, meibomian gland dysfunction, blurred vision, increased lacrimation, photophobia, visual impairment, skin hyperpigmentation, and madarosis. Table 7: Select Laboratory Abnormalities (≥20%) in Patients Who Received DATROWAY in TROPION-Breast01 Laboratory Abnormality DATROWAY The denominator used to calculate the rate varied from 264 to 359 based on the number of patients with a baseline value and at least one post-treatment value. Chemotherapy All Grades % Grades 3-4 % All Grades % Grades 3-4 % Frequencies were based on NCI CTCAE v5.0 grade-derived laboratory abnormalities. Hematology Decreased leukocytes 41 1.1 63 18 Decreased lymphocytes 36 9 42 11 Decreased hemoglobin 35 2.8 51 4.4 Decreased neutrophils 30 1.6 61 35 Chemistry Decreased calcium 39 1.4 43 1.2 Increased AST 23 1.9 28 0.9 Increased ALT 24 1.7 31 0.6 Increased alkaline phosphatase 23 0.6 20 0.6"],"contraindications":["4 CONTRAINDICATIONS None. None. ( 4 )"],"how_supplied_table":["
Carton ContentsNDC
One 100 mg single-dose vialNDC 65597-801-01
"],"spl_medguide_table":["
This Medication Guide has been approved by the U.S. Food and Drug Administration.Revised: 06/2025
MEDICATION GUIDE DATROWAY® (DAT-roe-way) (datopotamab deruxtecan-dlnk) for injection, for intravenous use
What is the most important information I should know about DATROWAY? DATROWAY can cause serious side effects, including:Lung problems that may be severe, life-threatening, or that may lead to death. If you develop lung problems your healthcare provider may treat you with corticosteroid medicines. Tell your healthcare provider right away if you get any of the following signs and symptoms:coughtrouble breathing or shortness of breathfeverother new or worsening breathing symptoms such as chest tightness or wheezingEye problems. Eye problems are common with DATROWAY and can also be severe. Tell your healthcare provider right away if you develop any new or worsening eye problems during treatment with DATROWAY, including dry eyes, eye pain, eye redness, eye swelling, eye irritation, increased tears, feeling like something is in your eyes, discharge from your eyes, eye crusting, sensitivity to light, blurred vision, or vision changes.You should use preservative-free lubricating eye drops at least 4 times a day and as needed.Do not wear contact lenses during treatment with DATROWAY unless your eye specialist tells you to.Your healthcare provider will send you to an eye specialist to check your eyes when you start your treatment with DATROWAY, every year during treatment, at the end of treatment, and as needed for any new or worsening signs and symptoms of eye problems.Mouth ulcers and sores. Mouth ulcers and sores are common with DATROWAY and can also be severe. Tell your healthcare provider right away if you develop mouth pain, swelling, redness, ulcers, or sores during treatment with DATROWAY.Your healthcare provider will prescribe a steroid-containing mouthwash to use 4 times a day and as needed during treatment with DATROWAY.You should hold ice chips or ice water in your mouth during your DATROWAY infusions.Your healthcare provider will check you for these side effects during your treatment with DATROWAY. Your healthcare provider may reduce your dose, delay treatment, or completely stop treatment with DATROWAY if you have severe side effects.Harm to your unborn baby. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with DATROWAY.If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with DATROWAY.Females who are able to become pregnant should use effective birth control (contraception) during treatment with DATROWAY and for 7 months after the last dose.Males who have female partners that are able to become pregnant should use effective birth control (contraception) during treatment with DATROWAY and for 4 months after the last dose.See "What are the possible side effects of DATROWAY?" for more information about side effects.
What is DATROWAY? DATROWAY is a prescription medicine used to treat adults who have:non-small cell lung cancer (NSCLC) that has certain mutations in a gene called epidermal growth factor receptor (EGFR):that has spread to areas outside of the lung (locally advanced) or has spread to other parts of the body (metastatic), andwho have received prior EGFR-directed medicine and platinum-based chemotherapy.hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer:that cannot be removed by surgery (unresectable) or has spread to other parts of the body (metastatic), andwho have received prior endocrine-based therapy and chemotherapy treatment for unresectable or metastatic disease. It is not known if DATROWAY is safe and effective in children.
Before receiving DATROWAY, tell your healthcare provider about all of your medical conditions, including if you:have lung or breathing problems.have eye problems. use contact lenses.are breastfeeding or plan to breastfeed. It is not known if DATROWAY passes into your breast milk. Do not breastfeed during treatment with DATROWAY 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.
How will I receive DATROWAY?You will receive DATROWAY into your vein through an intravenous (IV) line by your healthcare provider.DATROWAY is usually given 1 time every three weeks (21-day treatment cycle).You will receive your first infusion over 90 minutes. If you do not have problems with your first infusion, you may receive your next infusions over 30 minutes.You will be monitored for side effects for at least 1 hour after your first 2 infusions. If you do not have problems after your second infusion, you will be monitored for at least 30 minutes after each following infusion.Your healthcare provider will decide how many treatments you need.Your healthcare provider will give you medicines before your infusion to help prevent nausea, vomiting, and infusion-related reactions.Your healthcare provider may slow down or temporarily stop your infusion of DATROWAY if you have an infusion-related reaction, or permanently stop DATROWAY if you have severe infusion reactions.If you miss a planned dose of DATROWAY, call your healthcare provider right away to schedule an appointment. Do not wait until the next planned treatment cycle.
What are the possible side effects of DATROWAY? DATROWAY can cause serious side effects, including:See "What is the most important information I should know about DATROWAY?"The most common side effects of DATROWAY when used in adults with EGFR-mutated non-small cell lung cancer include:
nauseahair losstirednessdecreased red blood cell countsdecreased white blood cell countsconstipationincreased blood levels of calciumincreased blood levels of liver enzymesincreased levels of enzyme called lactate dehydrogenase in the bloodmuscle and joint painrashdecreased appetite
The most common side effects of DATROWAY when used in adults with HR-positive HER2-negative breast cancer include:
nauseatirednessdecreased white blood cell countsdecreased blood levels of calciumhair lossdecreased red blood cell countsconstipationdry eyevomiting increased blood levels of liver enzymesan eye problem called keratitis. See "What is the most important information I should know about DATROWAY?"increased blood levels of alkaline phosphatase
DATROWAY may cause fertility problems in males and females, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility. These are not all of the possible side effects of DATROWAY. 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 DATROWAY. 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 DATROWAY that is written for health professionals.
What are the ingredients in DATROWAY? Active ingredient: datopotamab deruxtecan-dlnk Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, and sucrose Manufactured by: Daiichi Sankyo, Inc., Basking Ridge, NJ 07920 U.S. License No. 2128 Marketed by: Daiichi Sankyo, Inc., Basking Ridge, NJ 07920 and AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 DATROWAY® is a registered trademark of Daiichi Sankyo Company, Ltd. © 2025 Daiichi Sankyo Co., Ltd. USMG-DAT-C7-0625-r002 For more information, call 1-877-437-7763 or go to https://www.DATROWAY.com.
"],"mechanism_of_action":["12.1 Mechanism of Action Datopotamab deruxtecan-dlnk, is a Trop-2-directed antibody-drug conjugate. The antibody is a humanized anti-Trop2 IgG1. The small molecule, DXd, is a topoisomerase I inhibitor attached to the antibody by a cleavable linker. Following binding to Trop-2 on cells, including tumor cells, datopotamab deruxtecan-dlnk undergoes internalization and intracellular linker cleavage by lysosomal enzymes. Upon release, the membrane-permeable DXd causes DNA damage and apoptotic cell death. Datopotamab deruxtecan-dlnk had anti-tumor activity in mouse models of lung cancer including EGFR-mutated and breast cancer."],"storage_and_handling":["Storage and Handling Store vials in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF) in the original carton to protect from light until time of reconstitution. Do not freeze. Do not shake the reconstituted or diluted solution [see Dosage and Administration (2.5) ] . DATROWAY (datopotamab deruxtecan-dlnk) is a hazardous drug. Follow applicable special handling and disposal procedures. 1"],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Datopotamab deruxtecan-dlnk, is a Trop-2-directed antibody-drug conjugate. The antibody is a humanized anti-Trop2 IgG1. The small molecule, DXd, is a topoisomerase I inhibitor attached to the antibody by a cleavable linker. Following binding to Trop-2 on cells, including tumor cells, datopotamab deruxtecan-dlnk undergoes internalization and intracellular linker cleavage by lysosomal enzymes. Upon release, the membrane-permeable DXd causes DNA damage and apoptotic cell death. Datopotamab deruxtecan-dlnk had anti-tumor activity in mouse models of lung cancer including EGFR-mutated and breast cancer. 12.2 Pharmacodynamics Datopotamab deruxtecan-dlnk time course of pharmacodynamic response is unknown. Exposure-Response Relationships A relationship between datopotamab deruxtecan-dlnk exposure and efficacy has not been fully characterized in breast cancer or EGFR-mutated NSCLC. In the pooled population of NSCLC (including EGFR-mutated NSCLC) and breast cancer patients, higher datopotamab deruxtecan-dlnk systemic exposure is associated with a higher incidence rate of serious adverse reactions, dosage interruptions, dose reductions, stomatitis/oral mucositis, ocular adverse reactions, and Grade ≥3 adverse reactions. Cardiac Electrophysiology At datopotamab deruxtecan-dlnk doses up to 10 mg/kg (1.7 times the recommended dose), mean increase in the QTc interval >20 ms was not observed. 12.3 Pharmacokinetics Datopotamab deruxtecan-dlnk and DXd exposure after the first dose of the approved recommended dosage of cycle 1 are provided in Table 8. Datopotamab deruxtecan-dlnk and released DXd maximum concentration (C max ) and area under the time-concentration curve (AUC) increases proportionally over a dose range of 4 mg/kg to 10 mg/kg (approximately 0.7 to 1.7 times the approved recommended dosage). No clinically significant datopotamab deruxtecan-dlnk accumulation occurs between cycles 1 and 3. Table 8: Datopotamab Deruxtecan-dlnk and DXd Mean (CV%) Exposure After the First Dose PK Parameter Datopotamab deruxtecan-dlnk DXd Abbreviations: C max =maximum concentration; AUC =area under the time-concentration curve C max 154 µg/mL (20%) 2.8 ng/mL (58%) AUC 671 µg*day/mL (31%) 18 ng*day/mL (43%) Distribution Datopotamab deruxtecan-dlnk mean steady state volume of distribution is 3.5 (23%) L. DXd plasma protein binding is approximately 98% and the blood-to-plasma concentration ratio is 0.6 in vitro. Elimination The datopotamab deruxtecan-dlnk median elimination half-life (t 1/2 ) is 4.8 days (1.0, 8.2) and the released DXd median apparent t 1/2 is approximately 5.5 days (3.2, 8.8). The estimated datopotamab deruxtecan-dlnk clearance is 0.6 (31.5%) L/day. Metabolism Datopotamab deruxtecan-dlnk undergoes intracellular cleavage by lysosomal enzymes to release DXd . The humanized Trop-2 IgG1 monoclonal antibody is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG. In vitro, DXd is primarily metabolized by CYP3A4. Specific Populations The mean volume of distribution and clearance of datopotamab deruxtecan-dlnk and DXd increase with increasing body weight (36 kg to 156 kg). No clinically significant differences in the pharmacokinetics of datopotamab deruxtecan-dlnk or DXd were observed based on age (26 to 86 years), race (Asian, White, or Black), sex, mild hepatic impairment (total bilirubin ≤ULN and any AST >ULN or total bilirubin >1 to 1.5 times ULN and any AST), or mild to moderate renal impairment (CLcr 30 to <90 mL/min). The pharmacokinetics of datopotamab deruxtecan-dlnk in patients with moderate hepatic impairment (total bilirubin >1.5 to 3 times ULN and any AST) was comparable to patients with normal hepatic function (total bilirubin and AST ≤ULN). The steady state average DXd AUC was 2.4-fold higher in patients with moderate hepatic impairment compared to patients with normal hepatic function. The effect of severe hepatic impairment (total bilirubin >3 times ULN and any AST) or severe renal impairment (CLcr <30 mL/min) on datopotamab deruxtecan-dlnk or DXd pharmacokinetics is unknown. Drug Interaction Studies Clinical Studies and Model-Informed Approaches No clinically significant differences in DXd pharmacokinetics were predicted when used concomitantly with itraconazole (strong CYP3A inhibitor) or ritonavir (dual OATP1B and CYP3A inhibitor). In Vitro Studies CYP450 Enzymes : DXd does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A and does not induce CYP1A2, CYP2B6, or CYP3A. UDP-Glucuronosyltransferase (UGT): DXd does not undergo significant metabolism by UGT enzymes. Transporters Systems : DXd is a substrate of OATP1B1, OATP1B3, MATE2-K, P-gp, MRP1, and BCRP. DXd does not inhibit OAT1, OAT3, OCT1, OCT2, OATP1B1, OATP1B3, MATE1, MATE2-K, P-gp, BCRP, or BSEP transporters. 12.6 Immunogenicity There is insufficient information from TROPION-Breast01, TROPION-Lung01, and TROPION-Lung05 to characterize the anti-drug antibody response to datopotamab deruxtecan-dlnk and the effects of anti-drug antibodies on pharmacokinetics, pharmacodynamics, safety, or effectiveness of datopotamab deruxtecan-dlnk products."],"indications_and_usage":["1 INDICATIONS AND USAGE DATROWAY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of: adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. ( 1.1 ) This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. ( 1.2 ) 1.1 Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC) DATROWAY is indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. 1.2 Unresectable or Metastatic, HR-Positive, HER2-Negative Breast Cancer DATROWAY is indicated for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease."],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS Interstitial Lung Disease (ILD) and Pneumonitis: DATROWAY can cause severe and fatal cases of ILD/pneumonitis. Monitor for new or worsening signs and symptoms of ILD/pneumonitis. If ILD/pneumonitis is suspected, withhold DATROWAY and initiate corticosteroids. Permanently discontinue DATROWAY in patients with confirmed Grade 2 or higher ILD/pneumonitis. ( 5.1 ) Ocular Adverse Reactions: DATROWAY can cause ocular adverse reactions including dry eye, keratitis, blepharitis, meibomian gland dysfunction, increased lacrimation, conjunctivitis, and blurred vision. Monitor patients for ocular adverse reactions during treatment with DATROWAY. Advise patients to use preservative-free lubricating eye drops and to avoid using contact lenses during treatment with DATROWAY. Withhold, reduce the dose, or permanently discontinue DATROWAY based on the severity of ocular adverse reactions. Refer patients to an eye care professional for any new or worsening ocular signs and symptoms. ( 2.3 , 2.4 , 5.2 ) Stomatitis/Oral Mucositis: DATROWAY can cause stomatitis, including mouth ulcers and oral mucositis. Advise patients to use a steroid-containing mouthwash when starting treatment and to hold ice chips or ice water in mouth during the infusion of DATROWAY. Withhold, reduce the dose, or permanently discontinue DATROWAY based on severity. ( 2.3 , 2.4 , 5.3 ) Embryo-Fetal Toxicity : DATROWAY can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. ( 5.4 , 8.1 , 8.3 ) 5.1 Interstitial Lung Disease/Pneumonitis DATROWAY can cause severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis. Locally Advanced or Metastatic NSCLC In the pooled safety population of 484 patients with NSCLC from TROPION-Lung01, TROPION-Lung05, and TROPION-PanTumor01 [see Adverse Reactions (6.1) ], ILD/pneumonitis occurred in 7% of patients treated with DATROWAY, including 0.6% of patients with Grade 3 and 0.4% with Grade 4. There were 8 (1.7%) fatal cases. The median time to onset for ILD was 1.4 months (range: 0.2 months to 9 months). Eleven patients (2.3%) had DATROWAY withheld and 20 patients (4.1%) permanently discontinued DATROWAY due to ILD/pneumonitis. Systemic corticosteroids were required in 79% (26/33) of patients with ILD/pneumonitis. ILD/pneumonitis resolved in 45% of patients. Unresectable or Metastatic Breast Cancer In the pooled safety population of 443 patients with breast cancer from TROPION-Breast01 and TROPION-PanTumor01 [see Adverse Reactions (6.1) ], ILD/pneumonitis occurred in 3.6% of patients treated with DATROWAY, including 0.7% of patients with Grade 3. There was one fatal case (0.2%). The median time to onset for ILD was 2.8 months (range: 1.1 months to 10.8 months). Four patients (0.9%) had DATROWAY withheld and 7 patients (1.6%) permanently discontinued DATROWAY due to ILD/pneumonitis. Systemic corticosteroids were required in 60% (9/15) of patients with ILD/pneumonitis. ILD/pneumonitis resolved in 40% of patients. Patients were excluded from clinical studies for a history of ILD/pneumonitis requiring treatment with steroids or for ongoing ILD/pneumonitis. Monitor patients for new or worsening respiratory symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever) during treatment with DATROWAY. For asymptomatic (Grade 1) ILD/pneumonitis, consider corticosteroid treatment (e.g., ≥0.5 mg/kg/day prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater), promptly initiate systemic corticosteroid treatment (e.g., ≥1 mg/kg/day prednisolone or equivalent) and continue for at least 14 days followed by gradual taper for at least 4 weeks. Withhold DATROWAY in patients with suspected ILD/pneumonitis and permanently discontinue DATROWAY if ≥Grade 2 ILD/pneumonitis is confirmed [see Dosage and Administration (2.4) ]. 5.2 Ocular Adverse Reactions DATROWAY can cause ocular adverse reactions including dry eye, keratitis, blepharitis, meibomian gland dysfunction, increased lacrimation, conjunctivitis, and blurred vision. In the pooled safety population [see Adverse Reactions (6.1) ] , ocular adverse reactions occurred in 36% of patients treated with DATROWAY. Twenty patients (2.2%) experienced Grade 3 ocular adverse reactions, which included keratitis, dry eye, and blurred vision, and one patient experienced a Grade 4 ocular adverse reaction of conjunctival hemorrhage. The most common (≥5%) ocular adverse reactions were dry eye (17%), keratitis (14%), and increased lacrimation (7%). The median time to onset for ocular adverse reactions was 2.3 months (range: 0.03 months to 23.2 months). Of the patients who experienced ocular adverse reactions, 39% had complete resolution, and 10% had partial improvement (defined as a decrease in severity by one or more grades from the worst grade at last follow up). Ocular adverse reactions led to dosage interruption in 3.6% of patients, dosage reductions in 2.5% of patients, and permanent discontinuation of DATROWAY in 1% of patients. Patients with clinically significant corneal disease were excluded from clinical studies. Advise patients to use preservative-free lubricant eye drops several times daily for prophylaxis. Advise patients to avoid use of contact lenses unless directed by an eye care professional. Refer patients to an eye care professional for an ophthalmic exam including visual acuity testing, slit lamp examination (with fluorescein staining), intraocular pressure, and fundoscopy at treatment initiation, annually while on treatment, at end of treatment, and as clinically indicated. Promptly refer patients to an eye care professional for any new or worsening ocular adverse reactions. Monitor patients for ocular adverse reactions during treatment with DATROWAY, and if diagnosis is confirmed, withhold, reduce the dose, or permanently discontinue DATROWAY based on severity [see Dosage and Administration (2.4) ] . 5.3 Stomatitis DATROWAY can cause stomatitis, including mouth ulcers and oral mucositis. In the pooled safety population [see Adverse Reactions (6.1) ], stomatitis occurred in 63% of patients treated with DATROWAY, including 8% of patients with Grade 3 events and one patient with a Grade 4 reaction. The median time to first onset of stomatitis was 0.5 months (range: 0.03 months to 18.6 months). Stomatitis led to dosage interruption in 6% of patients, dosage reductions in 11% of patients, and permanent discontinuation of DATROWAY in 0.5% of patients. In patients who received DATROWAY in TROPION-Breast01, 39% used a mouthwash containing corticosteroid for management or prophylaxis of stomatitis/oral mucositis at any time during the treatment. Advise patients to use a steroid-containing mouthwash for prophylaxis and treatment of stomatitis. Instruct the patient to hold ice chips or ice water in the mouth throughout the infusion of DATROWAY. Monitor patients for signs and symptoms of stomatitis. If stomatitis occurs, increase the frequency of mouthwash and administer other topical treatments as clinically indicated. Based on the severity of the adverse reaction, withhold, reduce the dose, or permanently discontinue DATROWAY [see Dosage and Administration (2.4) ]. 5.4 Embryo-Fetal Toxicity Based on its mechanism of action, DATROWAY can cause embryo-fetal harm when administered to a pregnant woman because the topoisomerase inhibitor component of DATROWAY, DXd [see Description (11) ] , is genotoxic and affects actively dividing cells [see Use in Specific Populations (8.1) , Clinical Pharmacology (12.1) , Nonclinical Toxicology (13.1) ]. Advise patients of the potential risk to a fetus. Advise female patients of reproductive potential to use effective contraception during treatment with DATROWAY and for 7 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with DATROWAY and for 4 months after the last dose [see Use in Specific Populations (8.1 , 8.3) ]."],"clinical_studies_table":["
Table 9: Efficacy Results in TROPION-Lung05 and TROPION-Lung01 by BICR
DATROWAY TL05 N=77DATROWAY TL01 N=37DATROWAY Pooled N=114
CI: confidence interval
Overall Response Rate (95% CI)45% (34, 57)43% (27, 61)45% (35, 54)
Complete Response5%2.7%4.4%
Partial Response40%41%40%
Duration of Response Median, months (95% CI) 6.9 (4.2, 10.2)6.5 (4.0, 8.4)6.5 (4.2, 8.4)
≥6 months49%44%47%
≥12 months23%6%18%
","
Table 10: Efficacy Results in TROPION-Breast01
DATROWAY (n=365)Chemotherapy (n=367)
CI: Confidence interval; NS: not statistically significant
Progression-Free Survival Assessed by BICR
Number of events (%)212 (58)235 (64)
Progressive Disease201 (55)218 (59)
Death11 (3)17 (5)
Median, months (95% CI)6.9 (5.7, 7.4)4.9 (4.2, 5.5)
Hazard ratio (95% CI) Based on the stratified Cox proportional hazards model0.63 (0.52, 0.76)
p-value Two-sided p-value based on stratified log-rank test., p-value is compared with the allocated alpha of 0.01.< 0.0001
Overall Survival
Number of events (%)223 (61)213 (58)
Median, months (95% CI)18.6 (17.3, 20.1)18.3 (17.3, 20.5)
Hazard ratio (95% CI) 1.01 (0.83, 1.22)
p-value NS
Confirmed Objective Response Rate
n (%)133 (36)84 (23)
(95% CI)31, 4219, 28
Complete Response n (%)2 (0.5)0
Partial Response n (%)131 (36)84 (23)
Duration of Response
Median, months (95% CI)6.7 (5.6, 9.8)5.7 (4.9, 6.8)
","
Figure 1: Kaplan-Meier Plot of PFS by BICR in TROPION-Breast-01
"],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies have not been conducted with datopotamab deruxtecan-dlnk. The topoisomerase inhibitor component of datopotamab deruxtecan-dlnk, DXd, was clastogenic in both an in vivo rat bone marrow micronucleus assay and an in vitro Chinese hamster lung chromosome aberration assay and was not mutagenic in an in vitro bacterial reverse mutation assay. Dedicated fertility studies have not been conducted with datopotamab deruxtecan-dlnk. In a 3-month repeat-dose toxicity study, intravenous administration of datopotamab deruxtecan-dlnk once every 3 weeks in rats resulted in decreased weights in the testes and epididymides, degeneration of the germinal epithelium and atrophy of seminiferous tubules in testes, and cell debris, decreased number of sperm, and single-cell necrosis of the ductal epithelium in epididymides at 200 mg/kg (approximately 29 times the human recommended dose of 6 mg/kg based on AUC). Findings in female rats included increased atretic follicles in the ovary and single cell necrosis of mucosal epithelium in the vagina at 200 mg/kg. These findings, except for the lesions in the testis and epididymis, were not observed after a 2-month recovery period."],"pharmacokinetics_table":["
Table 8: Datopotamab Deruxtecan-dlnk and DXd Mean (CV%) Exposure After the First Dose
PK ParameterDatopotamab deruxtecan-dlnk DXd
Abbreviations: Cmax =maximum concentration; AUC =area under the time-concentration curve
Cmax154 µg/mL (20%)2.8 ng/mL (58%)
AUC671 µg*day/mL (31%)18 ng*day/mL (43%)
"],"adverse_reactions_table":["
Table 4: Adverse Reactions (≥10%) in Patients with Locally Advanced or Metastatic EGFR-Mutated NSCLC Who Received DATROWAY in TROPION-Lung05, TROPION-Lung01, and TROPION-PanTumor01
Adverse ReactionDATROWAY N=125
All Grades %Grades 3 or 4 %
Events were graded using NCI CTCAE v5.0.
Gastrointestinal disorders
StomatitisIncludes other related terms719
Nausea500
Constipation310
Vomiting160.8
Diarrhea120
Skin and subcutaneous tissue disorders
Alopecia490
Rash200.8
Pruritus120
General disorders and administration site conditions
FatigueIncludes fatigue, asthenia, and malaise426
Musculoskeletal and connective tissue disorders
Musculoskeletal pain220.8
Metabolism and nutrition disorders
Decreased appetite201.6
Infections and Infestations
COVID-19192.4
Respiratory, Thoracic, and Mediastinal Disorders
Cough180
Dyspnea112.4
Eye disorders
Dry eye130
KeratitisIncludes corneal disorder, corneal erosion, keratitis, punctate keratitis, and ulcerative keratitis122.4
Injury, poisoning and procedural complications
Infusion-related reaction130
Nervous system disorders
Headache130
","
Table 5: Select Laboratory Abnormalities (≥20%) that Worsened from Baseline in Patients with Locally Advanced or Metastatic EGFR-Mutated NSCLC Who Received DATROWAY in TROPION-Lung05, TROPION-Lung01, and TROPION-PanTumor01
Laboratory AbnormalityFrequencies were based on NCI CTCAE v5.0 grade-derived laboratory abnormalities.DATROWAYThe denominator used to calculate the rate varied from 115 to 124 based on the number of patients with a baseline value and at least one post-treatment value.
All Grades %Grades 3 or 4 %
Hematology
Decreased hemoglobin344.8
Decreased lymphocytes3211
Decreased white blood cell count271.6
Chemistry
Increased calcium310
Increased AST282.4
Increased lactate dehydrogenase230
Increased ALT202.4
","
Table 6: Adverse Reactions (≥10%) in Patients Who Received DATROWAY in TROPION-Breast01
Adverse ReactionsDATROWAY N=360Chemotherapy N=351
All Grades %Grades 3 or 4 %All Grades %Grades 3 or 4 %
Events were graded using NCI CTCAE v5.0.
Gastrointestinal Disorders
Stomatitis Includes other related terms.597172.6
Nausea561.4270.6
Constipation340.3170
Vomiting241.1121.1
Diarrhea110.6191.4
Abdominal pain 110.6151.4
General Disorders and Administration Site Conditions
Fatigue Includes fatigue, asthenia, lethargy, malaise444.2403.7
Skin and Subcutaneous Tissue Disorders
Alopecia380220
Rash 190172.3
Eye Disorders
Dry eye270.8130
Keratitis Includes corneal disorder, corneal erosion, corneal infiltrates, corneal lesion, corneal toxicity, injury corneal, keratitis, keratopathy, punctate keratitis, and ulcerative keratitis241.1100
Metabolism and Nutrition Disorders
Decreased appetite161.4160.9
Infections and Infestations
COVID-19 161.4130.9
Respiratory, Thoracic, and Mediastinal Disorders
Cough 150100
","
Table 7: Select Laboratory Abnormalities (≥20%) in Patients Who Received DATROWAY in TROPION-Breast01
Laboratory AbnormalityDATROWAY The denominator used to calculate the rate varied from 264 to 359 based on the number of patients with a baseline value and at least one post-treatment value. Chemotherapy
All Grades %Grades 3-4 %All Grades %Grades 3-4 %
Frequencies were based on NCI CTCAE v5.0 grade-derived laboratory abnormalities.
Hematology
Decreased leukocytes411.16318
Decreased lymphocytes3694211
Decreased hemoglobin 352.8514.4
Decreased neutrophils301.66135
Chemistry
Decreased calcium 391.4431.2
Increased AST231.9280.9
Increased ALT241.7310.6
Increased alkaline phosphatase230.6200.6
"],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Interstitial Lung Disease/Pneumonitis Inform patients of the risks of severe or fatal ILD. Advise patients to contact their healthcare provider immediately for any of the following: cough, shortness of breath, fever, or other new or worsening respiratory symptoms [see Warnings and Precautions (5.1) ] . Ocular Adverse Reactions Inform patients about the need for eye exams at initiation and during treatment with DATROWAY [see Dosage and Administration (2.3) ] . Advise patients to contact their healthcare provider if they experience any eye symptoms [see Warnings and Precautions (5.2) ] . Advise patients to use preservative-free lubricating eye drops several times daily and to avoid use of contact lenses during treatment with DATROWAY [see Dosage and Administration (2.3 , 2.4) ] . Stomatitis Inform patients of the risk of stomatitis. Advise patients to contact their healthcare provider if they experience any symptoms . Inform patients to use a steroid-containing mouthwash for prophylaxis and treatment of stomatitis. Instruct patients to hold ice chips or ice water in their mouth throughout the infusion of DATROWAY [see Warnings and Precautions (5.3) ] . Embryo-Fetal Toxicity Inform female patients of the potential risk to a fetus. Advise female patients to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.4) , Use in Specific Populations (8.1) ] . Advise females of reproductive potential to use effective contraception during treatment with DATROWAY and for 7 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 with DATROWAY and for 4 months after the last dose [see Use in Specific Populations (8.3) ] . Lactation Advise women not to breastfeed during treatment and for 1 month after the last dose of DATROWAY [see Use in Specific Populations (8.2) ] . Infertility Advise males and females of reproductive potential that DATROWAY may impair fertility [see Use in Specific Populations (8.3) ] ."],"spl_unclassified_section":["Manufactured by: Daiichi Sankyo, Inc., Basking Ridge, NJ 07920 U.S. License No. 2128 Marketed by: Daiichi Sankyo, Inc., Basking Ridge, NJ 07920 and AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 DATROWAY ® is a registered trademark of Daiichi Sankyo Company, Ltd. © 2026 Daiichi Sankyo Co., Ltd. USPI-DAT-C8-0326-r003"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION Reconstitute DATROWAY with Sterile Water for Injection. ( 2.5 ) Dilute with 5% Dextrose Injection. ( 2.5 ) For intravenous infusion only. Do not administer as an intravenous push or bolus. DO NOT use Sodium Chloride Injection, USP. ( 2.5 ) Premedicate to reduce the risk of infusion reactions and nausea and vomiting. ( 2.3 ) The recommended dosage of DATROWAY is 6 mg/kg (up to a maximum of 540 mg for patients ≥90 kg) given as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. ( 2.3 , 2.4 ) 2.1 Patient Selection Select patients with locally advanced or metastatic NSCLC for treatment with DATROWAY based on the presence of epidermal growth factor receptor (EGFR) mutations in tumor or plasma specimens [see Clinical Studies (14.1) ] . Testing may be performed at any time from initial diagnosis and does not need to be repeated once EGFR mutation status has been established. 2.2 Recommended Dosage The recommended dosage of DATROWAY is 6 mg/kg (up to a maximum of 540 mg for patients ≥90 kg) administered as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. If a planned dose is delayed or missed, administer as soon as possible; do not wait until the next planned cycle. Adjust the schedule of administration to maintain a 3-week interval between doses. 2.3 Premedication, Concomitant Medications, and Required Eye Care Conduct an ophthalmic exam including visual acuity testing, slit lamp examination (with fluorescein staining), intraocular pressure, and fundoscopy at initiation of DATROWAY, annually while on treatment, at end of treatment, and as clinically indicated. Administer DATROWAY with the premedication and concomitant medications described in Table 1. Monitor patients for infusion-related reactions in a setting where cardiopulmonary resuscitation medication and equipment are available. Monitor patients for at least 1 hour for the first 2 cycles of DATROWAY infusions. If there are no infusion-related reactions observed, monitor patients for at least 30 minutes for all subsequent cycles of infusions. Table 1: Premedication and Concomitant Medications Premedication With or without systemic corticosteroid Examples (or equivalent) Timing of Treatment/Duration Eye drops [see Warnings and Precautions (5.2) ] Preservative-free lubricant eye drops Administer at least four times daily and as needed Mouthwash [see Warnings and Precautions (5.3) ] Steroid-containing mouthwash (dexamethasone oral solution 0.1 mg/mL) Administer four times daily and as needed Antihistamine [see Adverse Reactions (6.1) ] Diphenhydramine (25 to 50 mg) administered intravenously or orally Administer 30-60 minutes prior to each infusion Antipyretic [see Adverse Reactions (6.1) ] Acetaminophen (650 to 1,000 mg) administered intravenously or orally Administer 30-60 minutes prior to each infusion Antiemetics [see Adverse Reactions (6.1) ] 5-HT3 serotonin receptor antagonist or appropriate alternatives intravenously or oral Prior to each infusion and thereafter as needed 2.4 Dosage Modifications Dosage Modifications for Adverse Reactions The recommended dose reduction levels for adverse reactions are described in Table 2. Table 2: Recommended Dosage Reductions of DATROWAY for Adverse Reactions Dose Reductions Recommended Dose First 4 mg/kg (up to a maximum of 360 mg for patients ≥90 kg) Second 3 mg/kg (up to a maximum of 270 mg for patients ≥90 kg) Third Permanently discontinue Do not re-escalate the DATROWAY dose after a dose reduction. Permanently discontinue DATROWAY in patients who are unable to tolerate 3 mg/kg intravenously once every 3 weeks. The recommended dosage modifications and management of adverse reactions for DATROWAY are described in Table 3. Table 3: Dosage Modifications and Management of Adverse Reactions for DATROWAY Adverse Reaction Severity Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Dosage Modifications Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions (5.1) ] Asymptomatic ILD/pneumonitis Grade 1 Withhold DATROWAY until ILD/pneumonitis is completely resolved, then: if resolved in ≤28 days, maintain current dose. if resolved in >28 days, reduce one dose level (see Table 2 ). Consider corticosteroids as soon as ILD/pneumonitis is suspected. Symptomatic ILD/pneumonitis Grade 2 or greater Permanently discontinue DATROWAY. Administer corticosteroids as soon as ILD/pneumonitis is suspected. Keratitis [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] Nonconfluent superficial keratitis Monitor. Continue DATROWAY at current dose. Confluent superficial keratitis, a cornea epithelial defect, or 3-line or more loss in best corrected visual acuity Withhold DATROWAY until improved or resolved Restart DATROWAY at the same dose level or consider dose reduction (see Table 2 ). Corneal ulcer or stromal opacity or best corrected distance visual acuity 20/200 or worse Withhold DATROWAY until improved or resolved Restart DATROWAY at reduced dose level (see Table 2 ). Corneal perforation Permanently discontinue DATROWAY. Stomatitis [see Warnings and Precautions (5.3) ] Grade 1 Optimize prophylactic and supportive medications. Continue DATROWAY at current dose. Grade 2 Withhold DATROWAY until resolved to ≤Grade 1. Restart DATROWAY at the same dose level for first occurrence. Recurrence: consider restarting at reduced dose level (see Table 2 ). Grade 3 Withhold DATROWAY until resolved to ≤Grade 1. Restart DATROWAY at reduced dose level (see Table 2 ). Grade 4 Permanently discontinue DATROWAY. Infusion-Related Reactions (IRR) [see Adverse Reactions (6.1) ] Grade 1 Reduce DATROWAY infusion rate by 50% if IRR is suspected and monitor patient closely. Grade 2 Interrupt DATROWAY infusion and administer supportive care medications. If the event resolves or improves to Grade 1, restart the infusion at 50% rate. Administer all subsequent infusions at the reduced rate. Grade 3 or 4 Permanently discontinue DATROWAY. Other Non-Hematologic Adverse Reactions [see Adverse Reactions (6.1) ] Grade 3 Withhold dose until resolved to ≤Grade 1 or baseline Restart DATROWAY at reduced dose level (see Table 2 ). Grade 4 Permanently discontinue DATROWAY. 2.5 Preparation and Administration Reconstitute and further dilute DATROWAY prior to intravenous infusion. Use appropriate aseptic technique. DATROWAY (datopotamab deruxtecan-dlnk) is a hazardous drug. Follow applicable special handling and disposal procedures. 1 Reconstitution Reconstitute immediately before dilution. More than one vial may be needed for a full dose. Calculate the dose (mg), the total volume of reconstituted DATROWAY solution required, and the number of vial(s) of DATROWAY needed [see Dosage and Administration (2.2) ]. Reconstitute each 100 mg vial using a sterile syringe to slowly inject 5 mL of Sterile Water for Injection into each vial to obtain a final concentration of 20 mg/mL. Swirl the vial gently until completely dissolved. Do not shake. If not used immediately, refrigerate the reconstituted DATROWAY solution in the original vial at 2ºC to 8ºC (36°F to 46°F) for up to 48 hours from the time of reconstitution. Protect the vial from light. Do not freeze. The product does not contain a preservative. Discard unused reconstituted DATROWAY after 48 hours of refrigeration. Dilution Withdraw the calculated amount from the vial(s) using a sterile syringe. Inspect for particulate matter and discoloration prior to administration. The reconstituted solution should be clear and colorless to light yellow. Do not use if visible particles are observed or if the solution is cloudy or discolored. Dilute the calculated volume of reconstituted DATROWAY in an infusion bag containing 100 mL of 5% Dextrose Injection. DO NOT use Sodium Chloride Injection. DATROWAY is compatible with an infusion bag made of polyvinylchloride or polyolefin (polypropylene or copolymer of ethylene and propylene). Gently invert the infusion bag to thoroughly mix the solution. Do not shake. Cover the infusion bag to protect from light. If not used immediately, store at room temperature at up to 25ºC (77°F) for up to 4 hours including preparation or in a refrigerator at 2ºC to 8ºC (36°F to 46°F) for up to 24 hours. Do not freeze. Discard any unused portion left in the vial. Administration The maximum time from reconstitution of the vial through the end of administration should not exceed 48 hours. Discard if storage time exceeds these limits. If the prepared infusion solution was stored refrigerated at 2ºC to 8ºC (36°F to 46°F), allow the solution to reach room temperature prior to administration, protected from light. Inspect for particulate matter and discoloration prior to administration. Administer DATROWAY as an intravenous infusion only with an infusion line and tubing set made of polyvinyl chloride, polybutadiene or low-density polyethylene. Administer DATROWAY with a 0.2-micron in-line polytetrafluoroethylene, polyethersulfone or nylon 66 filter. Do NOT administer as an intravenous push or bolus. Cover the infusion bag to protect from light during administration. Do not mix DATROWAY with other drugs or administer other drugs through the same intravenous line. Instruct the patient to hold ice chips or ice water in the mouth throughout the infusion of DATROWAY. First infusion: Administer infusion over 90 minutes. Observe patients during the infusion and for at least 1 hour following the initial dose for signs or symptoms of infusion-related reactions. Second Infusion: If first infusion was tolerated, administer second infusion over 30 minutes. Observe patients during the infusion and for at least 1 hour after infusion. Subsequent Infusions: Administer infusion over 30 minutes if prior infusions were tolerated. Observe patients during the infusion and for at least 30 min after infusion."],"spl_product_data_elements":["DATROWAY Datopotamab Deruxtecan DATOPOTAMAB DERUXTECAN DATOPOTAMAB DERUXTECAN HISTIDINE HISTIDINE HYDROCHLORIDE MONOHYDRATE SUCROSE POLYSORBATE 80"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS For injection: 100 mg of datopotamab deruxtecan-dlnk as a white to yellowish white, lyophilized powder in a single-dose vial for reconstitution and further dilution. For injection: 100 mg lyophilized powder in a single-dose vial. ( 3 )"],"clinical_pharmacology_table":["
Table 8: Datopotamab Deruxtecan-dlnk and DXd Mean (CV%) Exposure After the First Dose
PK ParameterDatopotamab deruxtecan-dlnk DXd
Abbreviations: Cmax =maximum concentration; AUC =area under the time-concentration curve
Cmax154 µg/mL (20%)2.8 ng/mL (58%)
AUC671 µg*day/mL (31%)18 ng*day/mL (43%)
"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed. ( 8.2 ) Infertility: May impair fertility in males and females. ( 8.3 ) 8.1 Pregnancy Risk Summary Based on its mechanism of action, DATROWAY can cause embryo-fetal harm when administered to a pregnant woman because the topoisomerase inhibitor component of DATROWAY, DXd, is genotoxic and affects actively dividing cells [see Clinical Pharmacology (12.1) , Nonclinical Toxicology (13.1) ] . There are no available data on the use of DATROWAY in pregnant women to inform a drug-associated risk. 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 There were no animal reproductive or developmental toxicity studies conducted with datopotamab deruxtecan-dlnk. 8.2 Lactation Risk Summary There are no data regarding the presence of datopotamab deruxtecan-dlnk or its metabolites 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 women not to breastfeed during treatment with DATROWAY and for 1 month after the last dose. 8.3 Females and Males of Reproductive Potential DATROWAY can cause embryo-fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ]. Pregnancy Testing Verify pregnancy status of females of reproductive potential prior to initiation of DATROWAY. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with DATROWAY and for 7 months after the last dose. Males Because of the potential for genotoxicity, advise male patients with female partners of reproductive potential to use effective contraception during treatment with DATROWAY and for 4 months after the last dose [see Nonclinical Toxicology (13.1) ] . Infertility Based on findings in animal toxicity studies, DATROWAY may impair male and female reproductive function and fertility. The effects on reproductive organs in animals were irreversible [see Nonclinical Toxicology (13.1) ] . 8.4 Pediatric Use Safety and effectiveness of DATROWAY have not been established in pediatric patients. 8.5 Geriatric Use Of the 125 patients with EGFR-mutated NSCLC in TROPION-Lung05, TROPION-Lung01, TROPION-PanTumor01 treated with DATROWAY 6 mg/kg, 44% were ≥65 years of age and 10% were ≥75 years of age. No clinically meaningful differences in efficacy and safety were observed between patients ≥65 years of age versus younger patients. Of the 365 patients in TROPION-Breast01 treated with DATROWAY 6 mg/kg, 25% were ≥65 years of age and 5% were ≥75 years of age. Grade ≥3 and serious adverse reactions were more common in patients ≥65 years (42% and 25%, respectively) compared to patients <65 years (33% and 15%, respectively). In TROPION-Breast01, no other meaningful differences in safety or efficacy were observed between patients ≥65 years of age versus younger patients. 8.6 Renal Impairment A higher incidence of ILD/pneumonitis has been observed in patients with mild and moderate renal impairment (creatinine clearance [CLcr] 30 to <90 mL/min) [see Warnings and Precautions (5.1) ]. Monitor patients with renal impairment for increased adverse reactions, including respiratory reactions. No dosage adjustment is recommended in patients with mild to moderate renal impairment [see Clinical Pharmacology (12.3) ] . The effect of severe renal impairment (CLcr <30 mL/min) on the pharmacokinetics of datopotamab deruxtecan-dlnk or DXd is unknown. 8.7 Hepatic Impairment No dosage adjustment is recommended in patients with mild hepatic impairment (total bilirubin ≤ULN and any AST >ULN or total bilirubin >1 to 1.5 times ULN and any AST). Limited data are available in patients with moderate hepatic impairment (total bilirubin >1.5 to 3 times ULN and any AST). Monitor patients with moderate hepatic impairment for increased adverse reactions [see Dosage and Administration (2.4) ] . The recommended dosage of DATROWAY has not been established for patients with severe hepatic impairment (total bilirubin >3 times ULN and any AST) [see Clinical Pharmacology (12.3) ]."],"dosage_and_administration_table":["
Table 1: Premedication and Concomitant Medications
Premedication With or without systemic corticosteroid Examples (or equivalent)Timing of Treatment/Duration
Eye drops [see Warnings and Precautions (5.2)]Preservative-free lubricant eye dropsAdminister at least four times daily and as needed
Mouthwash [see Warnings and Precautions (5.3)]Steroid-containing mouthwash (dexamethasone oral solution 0.1 mg/mL)Administer four times daily and as needed
Antihistamine [see Adverse Reactions (6.1)]Diphenhydramine (25 to 50 mg) administered intravenously or orallyAdminister 30-60 minutes prior to each infusion
Antipyretic [see Adverse Reactions (6.1)]Acetaminophen (650 to 1,000 mg) administered intravenously or orallyAdminister 30-60 minutes prior to each infusion
Antiemetics [see Adverse Reactions (6.1)]5-HT3 serotonin receptor antagonist or appropriate alternatives intravenously or oralPrior to each infusion and thereafter as needed
","
Table 2: Recommended Dosage Reductions of DATROWAY for Adverse Reactions
Dose ReductionsRecommended Dose
First4 mg/kg (up to a maximum of 360 mg for patients ≥90 kg)
Second3 mg/kg (up to a maximum of 270 mg for patients ≥90 kg)
ThirdPermanently discontinue
","
Table 3: Dosage Modifications and Management of Adverse Reactions for DATROWAY
Adverse ReactionSeverity Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.Dosage Modifications
Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions (5.1)]Asymptomatic ILD/pneumonitis Grade 1Withhold DATROWAY until ILD/pneumonitis is completely resolved, then:if resolved in ≤28 days, maintain current dose.if resolved in >28 days, reduce one dose level (see Table 2).Consider corticosteroids as soon as ILD/pneumonitis is suspected.
Symptomatic ILD/pneumonitis Grade 2 or greaterPermanently discontinue DATROWAY.Administer corticosteroids as soon as ILD/pneumonitis is suspected.
Keratitis [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)]Nonconfluent superficial keratitisMonitor.Continue DATROWAY at current dose.
Confluent superficial keratitis, a cornea epithelial defect, or 3-line or more loss in best corrected visual acuityWithhold DATROWAY until improved or resolvedRestart DATROWAY at the same dose level or consider dose reduction (see Table 2).
Corneal ulcer or stromal opacity or best corrected distance visual acuity 20/200 or worseWithhold DATROWAY until improved or resolvedRestart DATROWAY at reduced dose level (see Table 2).
Corneal perforationPermanently discontinue DATROWAY.
Stomatitis [see Warnings and Precautions (5.3)]Grade 1Optimize prophylactic and supportive medications.Continue DATROWAY at current dose.
Grade 2Withhold DATROWAY until resolved to ≤Grade 1.Restart DATROWAY at the same dose level for first occurrence.Recurrence: consider restarting at reduced dose level (see Table 2).
Grade 3Withhold DATROWAY until resolved to ≤Grade 1. Restart DATROWAY at reduced dose level (see Table 2).
Grade 4Permanently discontinue DATROWAY.
Infusion-Related Reactions (IRR) [see Adverse Reactions (6.1)]Grade 1Reduce DATROWAY infusion rate by 50% if IRR is suspected and monitor patient closely.
Grade 2Interrupt DATROWAY infusion and administer supportive care medications.If the event resolves or improves to Grade 1, restart the infusion at 50% rate.Administer all subsequent infusions at the reduced rate.
Grade 3 or 4Permanently discontinue DATROWAY.
Other Non-Hematologic Adverse Reactions [see Adverse Reactions (6.1)]Grade 3Withhold dose until resolved to ≤Grade 1 or baselineRestart DATROWAY at reduced dose level (see Table 2).
Grade 4Permanently discontinue DATROWAY.
"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 100 mg Vial Carton NDC 65597-801-01 Rx only DATROWAY ® (datopotamab deruxtecan-dlnk) For Injection 100 mg per vial For Intravenous Infusion Only Reconstitute and dilute prior to administration. Single-dose vial. Discard unused portion. Dispense the enclosed Medication Guide to each patient. Hazardous Drug KEEP REFRIGERATED 1 vial Daiichi-Sankyo AstraZeneca PRINCIPAL DISPLAY PANEL - 100 mg Vial Carton"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies have not been conducted with datopotamab deruxtecan-dlnk. The topoisomerase inhibitor component of datopotamab deruxtecan-dlnk, DXd, was clastogenic in both an in vivo rat bone marrow micronucleus assay and an in vitro Chinese hamster lung chromosome aberration assay and was not mutagenic in an in vitro bacterial reverse mutation assay. Dedicated fertility studies have not been conducted with datopotamab deruxtecan-dlnk. In a 3-month repeat-dose toxicity study, intravenous administration of datopotamab deruxtecan-dlnk once every 3 weeks in rats resulted in decreased weights in the testes and epididymides, degeneration of the germinal epithelium and atrophy of seminiferous tubules in testes, and cell debris, decreased number of sperm, and single-cell necrosis of the ductal epithelium in epididymides at 200 mg/kg (approximately 29 times the human recommended dose of 6 mg/kg based on AUC). Findings in female rats included increased atretic follicles in the ovary and single cell necrosis of mucosal epithelium in the vagina at 200 mg/kg. These findings, except for the lesions in the testis and epididymis, were not observed after a 2-month recovery period."]},"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Intravenous","category":"route"},{"label":"Injectable","category":"form"},{"label":"Active","category":"status"},{"label":"Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC)","category":"indication"},{"label":"Unresectable or Metastatic, HR-Positive, HER2-Negative Breast Cancer","category":"indication"},{"label":"Daiichi Sankyo","category":"company"},{"label":"Approved 2020s","category":"decade"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"1109 reports"},{"date":"","signal":"DISEASE PROGRESSION","source":"FDA FAERS","actionTaken":"971 reports"},{"date":"","signal":"INTERSTITIAL LUNG DISEASE","source":"FDA FAERS","actionTaken":"944 reports"},{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"921 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"753 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"698 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"497 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"494 reports"},{"date":"","signal":"NO ADVERSE EVENT","source":"FDA FAERS","actionTaken":"354 reports"},{"date":"","signal":"PNEUMONITIS","source":"FDA FAERS","actionTaken":"353 reports"}],"commonSideEffects":[{"effect":"Stomatitis","drugRate":"63%","severity":"serious","_validated":true},{"effect":"Nausea","drugRate":"52%","severity":"serious","_validated":true},{"effect":"Fatigue","drugRate":"45%","severity":"serious","_validated":true},{"effect":"Alopecia","drugRate":"38%","severity":"serious","_validated":true},{"effect":"Constipation","drugRate":"28%","severity":"common","_validated":true},{"effect":"Decreased appetite","drugRate":"23%","severity":"common","_validated":true},{"effect":"Rash","drugRate":"23%","severity":"common","_validated":true},{"effect":"Vomiting","drugRate":"22%","severity":"common","_validated":true},{"effect":"Musculoskeletal pain","drugRate":"20%","severity":"common","_validated":true},{"effect":"COVID-19","drugRate":"19%","severity":"unknown","_validated":true},{"effect":"Decreased hemoglobin","drugRate":"9%","severity":"mild","_validated":true},{"effect":"Decreased lymphocytes","drugRate":"9%","severity":"mild","_validated":true},{"effect":"ILD/pneumonitis","drugRate":"2.4%","severity":"mild","_validated":true},{"effect":"Keratitis","drugRate":"2.4%","severity":"mild","_validated":true},{"effect":"Pneumonia","drugRate":"1.6%","severity":"mild","_validated":true},{"effect":"Abnormal hepatic function","drugRate":"1.6%","severity":"mild","_validated":true},{"effect":"Anemia","drugRate":"1.6%","severity":"mild","_validated":true},{"effect":"Decreased weight","drugRate":"1.6%","severity":"mild","_validated":true},{"effect":"Dyspnea","drugRate":"1.6%","severity":"mild","_validated":true},{"effect":"Infusion-related reaction","drugRate":"1.6%","severity":"mild","_validated":true},{"effect":"Diarrhea","drugRate":"0.8%","severity":"mild","_validated":true},{"effect":"Pruritus","drugRate":"0.8%","severity":"mild","_validated":true},{"effect":"Pulmonary embolism","drugRate":"0.6%","severity":"mild","_validated":true},{"effect":"Urinary tract infection","drugRate":"0.6%","severity":"mild","_validated":true},{"effect":"Acute kidney injury","drugRate":"reported","severity":"unknown"},{"effect":"Amylase increased","drugRate":"reported","severity":"unknown"},{"effect":"Cough","drugRate":"reported","severity":"unknown"},{"effect":"Dry eye","drugRate":"reported","severity":"unknown"},{"effect":"Hemiparesis","drugRate":"reported","severity":"unknown"},{"effect":"Headache","drugRate":"reported","severity":"unknown"}],"contraindications":[],"specialPopulations":{"Pregnancy":"DATROWAY can cause embryo-fetal harm when administered to a pregnant woman because the topoisomerase inhibitor component of DATROWAY, DXd, is genotoxic and affects actively dividing cells. There are no available data on the use of DATROWAY in pregnant women to inform a drug-associated risk. 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 There were no animal reproductive or developmental toxicity studies conducted with datopotamab deruxtecan-dlnk. Advise patients of the potential risks to a fetus. Advise women not to breastfeed during treatment with DATROWAY and for 1 month after the last dose. Pregnancy Testing Verify pregnancy status before initiating DATROWAY. ","Geriatric use":"Of the 125 patients with EGFR-mutated NSCLC in TROPION-Lung05, TROPION-Lung01, TROPION-PanTumor01 treated with DATROWAY 6 mg/kg, 44% were ≥65 years of age and 10% were ≥75 years of age. No clinically meaningful differences in efficacy and safety were observed between patients ≥65 years of age versus younger patients. Of the 365 patients in TROPION-Breast01 treated with DATROWAY 6 mg/kg, 25% were ≥65 years of age and 5% were ≥75 years of age. Grade ≥3 and serious adverse reactions were similar between patients ≥65 years of age and younger patients.","Paediatric use":"Safety and effectiveness of DATROWAY have not been established in pediatric patients."}},"trials":[],"aliases":[],"company":"Daiichi Sankyo","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=DERUXTECAN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:16:34.502498+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Deruxtecan","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T00:16:42.525132+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T00:16:53.436855+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:16:41.200161+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:16:28.232479+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DERUXTECAN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:16:41.945872+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:16:27.010355+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:16:27.010415+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":"2026-04-20T00:16:43.553203+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: DNA topoisomerase I inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:16:42.524764+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4297844/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:16:42.420078+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"BLA761394","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:16:27.010426+00:00"}},"allNames":"datroway","offLabel":[],"synonyms":["Datroway","DATOPOTAMAB DERUXTECAN"],"timeline":[{"date":"20240405","type":"positive","source":"OpenFDA","milestone":"FDA approval (Daiichi Sankyo)"}],"aiSummary":"Deruxtecan (Datroway), marketed by Daiichi Sankyo, is a targeted therapy for locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC). Its key strength lies in its mechanism of action, which effectively binds to and inhibits the growth of cancer cells. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.","approvals":[{"date":"20240405","orphan":false,"company":"DAIICHI SANKYO","regulator":"FDA"}],"brandName":"Datroway","ecosystem":[],"mechanism":{"modality":"Small Molecule","explanation":"Datopotamab deruxtecan-dlnk, is a Trop-2-directed antibody-drug conjugate. The antibody is a humanized anti-Trop2 IgG1. The small molecule, DXd, is a topoisomerase I inhibitor attached to the antibody by a cleavable linker. Following binding to Trop-2 on cells, including tumor cells, datopotamab deruxtecan-dlnk undergoes internalization and intracellular linker cleavage by lysosomal enzymes. Upon release, the membrane-permeable DXd causes DNA damage and apoptotic cell death. Datopotamab deruxtecan-dlnk had anti-tumor activity in mouse models of lung cancer including EGFR-mutated and breast cancer.","oneSentence":"Deruxtecan works by binding to and inhibiting the growth of cancer cells.","technicalDetail":"Deruxtecan is a topoisomerase I inhibitor that works by binding to the topoisomerase I enzyme, preventing it from repairing DNA damage and leading to cancer cell death."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Deruxtecan","title":"Deruxtecan","extract":"Deruxtecan is a chemical compound and a derivative of exatecan that acts as topoisomerase I inhibitor."},"commercial":{"launchDate":"2024","_launchSource":"OpenFDA (20240405, DAIICHI SANKYO)"},"references":[{"id":1,"url":"https://api.fda.gov/drug/label.json?search=openfda.generic_name:\"DERUXTECAN\"","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:\"DERUXTECAN\"","fields":["approvals","company"],"source":"OpenFDA Drugs@FDA"},{"id":3,"url":"https://clinicaltrials.gov/search?intr=deruxtecan","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":4,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=deruxtecan","fields":["publications"],"source":"PubMed/NCBI"},{"id":5,"url":"https://en.wikipedia.org/wiki/Deruxtecan","fields":["history","overview"],"source":"Wikipedia"}],"_enrichedAt":"2026-03-31T10:21:32.055021","_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T00:16:53.437821+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[],"genericName":"deruxtecan","indications":{"approved":[{"name":"Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC)","source":"OpenFDA Label","regulator":"FDA","eligibility":{"age":"adult","stage":"locally advanced or metastatic","biomarkers":"EGFR-mutated","prior treatment":"prior EGFR-directed therapy and platinum-based chemotherapy"}},{"name":"Unresectable or Metastatic, HR-Positive, HER2-Negative Breast Cancer","source":"OpenFDA Label","regulator":"FDA","eligibility":{"age":"adult","stage":"unresectable or metastatic","biomarkers":"HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-)","prior treatment":"prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease"}}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT05104866","phase":"PHASE3","title":"A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)","status":"ACTIVE_NOT_RECRUITING","sponsor":"AstraZeneca","isPivotal":true,"startDate":"2021-10-18","conditions":["Breast Cancer"],"enrollment":732,"completionDate":"2026-07-31"},{"nctId":"NCT07137416","phase":"PHASE1","title":"Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2026-10-05","conditions":["Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Invasive Breast Carcinoma","Locally Advanced Breast Carcinoma","Metastatic Breast Carcinoma","Metastatic HER2-Low Breast Carcinoma","Metastatic HER2-Positive Breast Carcinoma","Metastatic Hormone Receptor-Positive Breast Carcinoma","Metastatic Malignant Solid Neoplasm","Metastatic Triple-Negative Breast Carcinoma","Unresectable Breast Carcinoma","Unresectable HER2-Low Breast Carcinoma","Unresectable HER2-Positive Breast Carcinoma","Unresectable Hormone Receptor-Positive Breast Carcinoma","Unresectable Malignant Solid Neoplasm","Unresectable Triple-Negative Breast Carcinoma"],"enrollment":36,"completionDate":"2028-01-10"},{"nctId":"NCT05372614","phase":"PHASE1","title":"Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene","status":"SUSPENDED","sponsor":"National Cancer Institute (NCI)","startDate":"2022-10-05","conditions":["Metastatic Malignant Solid Neoplasm","Unresectable Malignant Solid Neoplasm"],"enrollment":33,"completionDate":"2027-01-23"},{"nctId":"NCT06311214","phase":"PHASE2","title":"Personalized Antibody-Drug Conjugate Therapy Based on RNA and Protein Testing for the Treatment of Advanced or Metastatic Solid Tumors (The ADC MATCH Screening and Treatment Trial)","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2025-03-18","conditions":["Advanced Malignant Solid Neoplasm","Metastatic Malignant Solid Neoplasm"],"enrollment":500,"completionDate":"2028-03-31"},{"nctId":"NCT07227597","phase":"PHASE1,PHASE2","title":"A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003)","status":"RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2026-01-29","conditions":["Small Cell Lung Cancer Extensive Stage"],"enrollment":170,"completionDate":"2030-12-30"},{"nctId":"NCT04585958","phase":"PHASE1","title":"Testing the Combination of DS-8201a and Olaparib in HER2-Expressing Cancers With Expansion in Patients With Platinum Resistant Ovarian Cancer","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2021-05-21","conditions":["Metastatic Malignant Solid Neoplasm","Platinum-Resistant Ovarian High Grade Serous Adenocarcinoma","Unresectable Malignant Solid Neoplasm"],"enrollment":55,"completionDate":"2026-12-31"},{"nctId":"NCT06364410","phase":"PHASE1","title":"Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients With Stomach or Other Solid Tumors","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2025-02-03","conditions":["Clinical Stage III Gastric Cancer AJCC v8","Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IV Gastric Cancer AJCC v8","Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Locally Advanced Gastric Carcinoma","Locally Advanced Gastroesophageal Junction Adenocarcinoma","Locally Advanced Malignant Solid Neoplasm","Metastatic Gastric Carcinoma","Metastatic Gastroesophageal Junction Adenocarcinoma","Metastatic Malignant Solid Neoplasm","Unresectable Gastric Carcinoma","Unresectable Gastroesophageal Junction Adenocarcinoma","Unresectable Malignant Solid Neoplasm"],"enrollment":48,"completionDate":"2027-07-08"},{"nctId":"NCT04616560","phase":"PHASE2","title":"Trastuzumab Deruxtecan for the Treatment of HER2+ Newly Diagnosed or Recurrent Osteosarcoma","status":"SUSPENDED","sponsor":"National Cancer Institute (NCI)","startDate":"2021-03-08","conditions":["Osteosarcoma","Recurrent Osteosarcoma"],"enrollment":77,"completionDate":"2027-12-31"},{"nctId":"NCT07012031","phase":"PHASE1,PHASE2","title":"Sotorasib in Combination With Trastuzumab Deruxtecan for the Treatment of Locally Advanced and Metastatic Non-small Cell Lung Cancer With a KRAS G12C Mutation","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2026-08-07","conditions":["Locally Advanced Lung Non-Small Cell Carcinoma","Metastatic Lung Non-Small Cell Carcinoma","Stage III Lung Cancer AJCC v8","Stage IV Lung Cancer AJCC v8"],"enrollment":37,"completionDate":"2027-06-14"},{"nctId":"NCT04704661","phase":"PHASE1","title":"Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2021-08-09","conditions":["Advanced Breast Carcinoma","Advanced Colon Carcinoma","Advanced Colorectal Carcinoma","Advanced Endometrial Carcinoma","Advanced Gastric Carcinoma","Advanced Gastroesophageal Junction Adenocarcinoma","Advanced Malignant Solid Neoplasm","Advanced Salivary Gland Carcinoma","Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Clinical Stage III Gastric Cancer AJCC v8","Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IV Gastric Cancer AJCC v8","Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","HER2-Positive Breast Carcinoma","Malignant Hepatobiliary Neoplasm","Metastatic Breast Carcinoma","Metastatic Colon Carcinoma","Metastatic Colorectal Carcinoma","Metastatic Endometrial Carcinoma","Metastatic Gastric Carcinoma","Metastatic Gastroesophageal Junction Adenocarcinoma","Metastatic Malignant Solid Neoplasm","Metastatic Salivary Gland Carcinoma","Stage III Colon Cancer AJCC v8","Stage III Colorectal Cancer AJCC v8","Stage III Major Salivary Gland Cancer AJCC v8","Stage III Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","Stage IV Colon Cancer AJCC v8","Stage IV Colorectal Cancer AJCC v8","Stage IV Major Salivary Gland Cancer AJCC v8","Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","Unresectable Breast Carcinoma","Unresectable Colon Carcinoma","Unresectable Colorectal Carcinoma","Unresectable Endometrial Carcinoma","Unresectable Gastric Carcinoma","Unresectable Gastroesophageal Junction Adenocarcinoma","Unresectable Malignant Solid Neoplasm","Unresectable Salivary Gland Carcinoma"],"enrollment":51,"completionDate":"2027-03-31"},{"nctId":"NCT02693535","phase":"PHASE2","title":"TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer","status":"RECRUITING","sponsor":"American Society of Clinical Oncology","startDate":"2016-03-14","conditions":["Lymphoma, Non-Hodgkin","Multiple Myeloma","Advanced Solid Tumors"],"enrollment":4200,"completionDate":"2028-12-31"},{"nctId":"NCT06941272","phase":"PHASE1,PHASE2","title":"A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01)","status":"RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2025-05-26","conditions":["Malignant Neoplasm"],"enrollment":50,"completionDate":"2030-12-30"},{"nctId":"NCT07497386","phase":"PHASE2","title":"A Trial of Trastuzumab Rezetecan in Unresectable Locally Recurrent/Metastatic Breast Cancer","status":"NOT_YET_RECRUITING","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2026-04","conditions":["Unresectable Locally Recurrent Breast Cancer","Unresectable Locally Metastatic Breast Cancer"],"enrollment":150,"completionDate":"2028-12"},{"nctId":"NCT07195344","phase":"PHASE4","title":"Study Aiming to Compare the Plasma Exposure of the Payload (Free-DXd) in Patients Treated by T-DXd for Locally Advanced or Metastatic Breast Cancer According to Their BMI.","status":"RECRUITING","sponsor":"Institut Claudius Regaud","startDate":"2025-10-15","conditions":["Locally Advanced or Metastatic Breast Cancers"],"enrollment":210,"completionDate":"2029-10"},{"nctId":"NCT06925737","phase":"PHASE3","title":"A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)","status":"RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2025-05-13","conditions":["Prostate Cancer","Prostatic Neoplasms"],"enrollment":1440,"completionDate":"2031-01-06"},{"nctId":"NCT04482309","phase":"PHASE2","title":"A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors","status":"ACTIVE_NOT_RECRUITING","sponsor":"AstraZeneca","startDate":"2020-08-18","conditions":["Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer","Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer"],"enrollment":477,"completionDate":"2027-07-30"},{"nctId":"NCT07371585","phase":"PHASE2","title":"Trastuzumab Deruxtecan in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management","status":"RECRUITING","sponsor":"SOLTI Breast Cancer Research Group","startDate":"2026-02-18","conditions":["Breast Cancer Stage IV"],"enrollment":300,"completionDate":"2030-07-01"},{"nctId":"NCT06843447","phase":"PHASE1,PHASE2","title":"A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003)","status":"RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2025-04-15","conditions":["Ovarian Cancer Recurrent"],"enrollment":280,"completionDate":"2029-03-27"},{"nctId":"NCT07060807","phase":"PHASE3","title":"A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)","status":"RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2025-07-21","conditions":["Breast Neoplasms"],"enrollment":1000,"completionDate":"2033-07-14"},{"nctId":"NCT05555732","phase":"PHASE3","title":"Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Daiichi Sankyo","startDate":"2023-01-11","conditions":["Metastatic Non Small Cell Lung Cancer"],"enrollment":1170,"completionDate":"2029-05-11"},{"nctId":"NCT06863272","phase":"PHASE1,PHASE2","title":"A Clinical Study of Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat Metastatic Castrate Resistant Prostate Cancer (mCRPC) 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