{"id":"tivdak","rwe":[],"tags":[],"safety":{"boxedWarnings":["WARNING: OCULAR TOXICITY • TIVDAK can cause severe ocular toxicities resulting in changes in vision, including severe vision loss, and corneal ulceration. [see Warnings and Precautions (5.1) ]. • Conduct an ophthalmic exam, including an assessment of ocular symptoms, visual acuity, and slit lamp exam of the anterior segment of the eye prior to initiation of TIVDAK, prior to every cycle for the first nine cycles, and as clinically indicated. [see Dosage and Administration (2.2) and Warnings and P"],"safetySignals":[{"date":"","signal":"ANAEMIA","source":"FDA FAERS","actionTaken":"Reported 12 times"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"Reported 12 times"},{"date":"","signal":"FEBRILE NEUTROPENIA","source":"FDA FAERS","actionTaken":"Reported 12 times"},{"date":"","signal":"DRY EYE","source":"FDA FAERS","actionTaken":"Reported 10 times"},{"date":"","signal":"NEUROPATHY PERIPHERAL","source":"FDA FAERS","actionTaken":"Reported 9 times"},{"date":"","signal":"CONJUNCTIVITIS","source":"FDA FAERS","actionTaken":"Reported 8 times"},{"date":"","signal":"DEHYDRATION","source":"FDA FAERS","actionTaken":"Reported 8 times"},{"date":"","signal":"MALIGNANT NEOPLASM PROGRESSION","source":"FDA FAERS","actionTaken":"Reported 8 times"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"Reported 8 times"},{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"Reported 8 times"}],"drugInteractions":[{"drug":"Strong CYP3A4 Inhibitors","action":"Monitor","effect":"increase unconjugated MMAE exposure"}],"commonSideEffects":[{"effect":"Hemoglobin decreased","drugRate":"45%","severity":"common","organSystem":""},{"effect":"Peripheral neuropathy","drugRate":"39%","severity":"common","organSystem":""},{"effect":"Conjunctival adverse reactions","drugRate":"38%","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"37%","severity":"common","organSystem":""},{"effect":"Fatigue","drugRate":"36%","severity":"common","organSystem":""},{"effect":"Aspartate aminotransferase increased","drugRate":"33%","severity":"common","organSystem":""},{"effect":"Epistaxis","drugRate":"33%","severity":"common","organSystem":""},{"effect":"Alopecia","drugRate":"31%","severity":"common","organSystem":""},{"effect":"Alanine aminotransferase increased","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Hemorrhage","drugRate":"28%","severity":"common","organSystem":""},{"effect":"Sodium decreased","drugRate":"25%","severity":"common","organSystem":""},{"effect":"Constipation","drugRate":"25%","severity":"common","organSystem":""}],"contraindications":["None. None."],"specialPopulations":{"Pregnancy":"Based on the mechanism of action and findings in animals, TIVDAK can cause fetal harm when administered to a pregnant woman. There are no available human data on TIVDAK use in pregnant women to inform a drug-associated risk. In an animal reproduction study, administration of the small molecule component of TIVDAK, MMAE, to pregnant rats during organogenesis caused embryo-fetal mortality and structural abnormalities at exposures below the clinical exposure at the recommended dose. Advise patients of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.","Geriatric use":"Of the 425 patients with cervical cancer treated with TIVDAK across clinical trials, 14% were ≥65 years of age and 2.4% were ≥75 years of age. Grade ≥3 adverse reactions occurred in 60% of patients ≥65 years and in 55% of patients <65 years. Drug was discontinued due to an adverse reaction in 25% of patients ≥65 years and in 13% of patients <65 years.","Paediatric use":"Safety and effectiveness of TIVDAK in pediatric patients have not been established. Nonclinical studies of tisotumab vedotin-tftv suggest a lack of anti-tumor activity and penetrance to brain based on limited in vivo data from tissue factor (TF)-expressing subcutaneous or orthotopic pediatric models of high‑grade gliomas/glioblastomas (HGG/GBM) and diffuse intrinsic pontine glioma (DIPG).","Renal impairment":"Not mentioned","Hepatic impairment":"Moderate or severe hepatic impairment: Exposure to MMAE and adverse reactions are increased. Avoid use."},"seriousAdverseEvents":[{"effect":"Serious adverse reactions (overall)","drugRate":"33%","severity":"serious"},{"effect":"Urinary tract infection","drugRate":"4.8%","severity":"serious"},{"effect":"Small intestinal obstruction","drugRate":"2.4%","severity":"serious"},{"effect":"Sepsis","drugRate":"2%","severity":"serious"},{"effect":"Abdominal pain","drugRate":"2%","severity":"serious"},{"effect":"Hemorrhage","drugRate":"2%","severity":"serious"},{"effect":"Acute kidney injury","drugRate":"0.4%","severity":"serious"},{"effect":"Pneumonia","drugRate":"0.4%","severity":"serious"},{"effect":"Stevens-Johnson syndrome","drugRate":"0.4%","severity":"serious"}]},"trials":[],"aliases":[],"company":"SEAGEN","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=tivdak","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:43:39.121801+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Tivdak","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-19T23:43:47.368136+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:43:46.005227+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:43:39.145221+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=tivdak","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:43:46.792167+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Coagulation factor III binding agent","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:43:47.367458+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4297841/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:43:47.272233+00:00"}},"allNames":"tisotumab vedotin","offLabel":[],"synonyms":["tisotumab vedotin","tisotumab vedotin-tftv","tivdak","HuMax-TF-ADC"],"timeline":[{"date":"2021-09-01","type":"positive","_source":"Wikipedia","milestone":"Tisotumab vedotin granted accelerated approval by United States Food and Drug Administration","regulator":"FDA"},{"date":"2021-09-20","type":"positive","_source":"FDA BLA761208","milestone":"FDA ORIG — SEAGEN","regulator":"FDA","description":""},{"date":"2023-07-26","type":"positive","_source":"FDA BLA761208","milestone":"FDA SUPPL — SEAGEN","regulator":"FDA","description":""},{"date":"2024-04-01","type":"positive","_source":"Wikipedia","milestone":"Tisotumab vedotin granted traditional approval by the US Food and Drug Administration","regulator":"FDA"},{"date":"2024-04-29","type":"positive","_source":"FDA BLA761208","milestone":"FDA SUPPL — SEAGEN","regulator":"FDA","description":""},{"date":"2025-01-01","type":"positive","_source":"Wikipedia","milestone":"Committee for Medicinal Products for Human Use adopted a positive opinion","regulator":"EMA"},{"date":"2025-03-01","type":"positive","_source":"Wikipedia","milestone":"Tisotumab vedotin authorized for medical use in the European Union","regulator":"none"},{"date":"2025-11-12","type":"positive","_source":"FDA BLA761208","milestone":"FDA SUPPL — SEAGEN","regulator":"FDA","description":""}],"_dailymed":{"setId":"c9fe3f32-4219-466e-acb9-3f609b4f4df1","title":"TIVDAK (TISOTUMAB VEDOTIN) INJECTION, POWDER, FOR SOLUTION [SEAGEN INC.]","labeler":""},"aiSummary":"Tisotumab vedotin, sold under the brand name Tivdak, is an antibody-drug conjugate used to treat cervical cancer. It is a combination of tisotumab, a monoclonal antibody against tissue factor, and monomethyl auristatin E (MMAE), a potent inhibitor of cell division. Tisotumab vedotin is administered by infusion into a vein. The drug targets tissue factor, a primary initiator of the extrinsic blood coagulation cascade. This mechanism leads to the disruption of the microtubule network in actively dividing cells, resulting in cell cycle arrest and apoptotic cell death. Tisotumab vedotin has shown clinical differentiation in treating recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The commercial significance of this drug is its potential to provide a new treatment option for patients with limited therapeutic alternatives.","brandName":"Tisotumab Vedotin","ecosystem":[],"isGeneric":true,"mechanism":{"target":"Tissue factor","novelty":"Best-in-class","targets":[{"gene":"F3","source":"DrugCentral","target":"Tissue factor","protein":"Tissue factor","activityType":"EC50"}],"modality":"Monoclonal Antibody","drugClass":"Antibody-Drug Conjugate (ADC)","explanation":"","oneSentence":"","technicalDetail":"Tisotumab vedotin is a TF-directed ADC that consists of a human IgG1 antibody against cell surface TF and a microtubule-disrupting agent, MMAE, attached via a protease-cleavable linker. The binding of the ADC to TF-expressing cancer cells leads to internalization and release of MMAE, which disrupts microtubules and induces cell death."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"_wikipedia":{"title":"Tisotumab vedotin","extract":"Tisotumab vedotin, sold under the brand name Tivdak, is an antibody-drug conjugate used to treat cervical cancer. It is a combination of tisotumab, a monoclonal antibody against tissue factor, and monomethyl auristatin E (MMAE), a potent inhibitor of cell division. It is administered by infusion into a vein.","wiki_history":"== History ==\nTisotumab vedotin was developed by Genmab in Utrecht, the Netherlands, and Copenhagen, Denmark, with the code name TF-011-MMAE. In September 2021, tisotumab vedotin was granted accelerated approval by United States Food and Drug Administration for the use of recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.","wiki_society_and_culture":"== Society and culture ==\n=== Legal status ===\nIn April 2024, tisotumab vedotin was granted traditional approval by the US Food and Drug Administration (FDA) for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.\n\nIn January 2025, the Committee for Medicinal Products for Human Use  of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Tivdak, intended for the treatment of recurrent or metastatic cervical cancer. Tisotumab vedotin was authorized for medical use in the European Union in March 2025.\n\n=== Names ===\nTisotumab vedotin is the international nonproprietary name. Tivdak is the brand name for tisotumab vedotin in the United States."},"commercial":{"launchDate":"2021","revenueYear":2025,"annualCostUS":"","_launchSource":"DrugCentral (FDA 2021-09-20, SEAGEN)","annualRevenue":147,"genericStatus":"Biologic — patent protected","revenueSource":"SEC 8-K Pfizer (2026-02-03)","currentRevenue":"","revenueCurrency":"USD","manufacturerCount":"1 approved manufacturers","patientPopulation":"Generic — multiple manufacturers","peakSalesEstimate":"","revenueConfidence":"verified (SEC filing)","revenueExtractedAt":"2026-04-01T11:46:22.944577","revenueExtractedBy":"revenue-sec"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5477","fields":["approvals","synonyms","ATC","pharmacokinetics","patents","indications","contraindications","interactions","targets"],"source":"DrugCentral"},{"id":2,"url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=tivdak","fields":["mechanism","safety","indications","administration"],"source":"FDA 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