{"entity":{"id":"tisotumab-vedotin","kind":"drug","name":"Tisotumab vedotin","aka":[],"tldr":"Tisotumab vedotin is an ADC against tissue factor, the first to show a survival benefit in recurrent cervical cancer.","summary":"Tisotumab vedotin is a fully human anti-tissue-factor IgG1 antibody joined to the microtubule inhibitor MMAE through a cleavable mc-vc-PABC linker; tissue factor is abundant on cervical cancer cells, and the released payload kills the target cell and its neighbours. It is given at 2 mg/kg every 3 weeks for recurrent or metastatic cervical cancer after chemotherapy. Accelerated approval in 2021 followed innovaTV 204, and full approval in 2024 followed innovaTV 301, in which overall survival was 11.5 versus 9.5 months against chemotherapy in second- and third-line disease, the first survival benefit in this setting. Conjunctival disorders affected 37 percent, so eye exams, steroid and vasoconstrictor drops and cold packs during infusion are required; epistaxis (26 percent) and haemorrhage (21 percent) reflect the tissue-factor target.","status":"approved","asOf":"2026-09-04","wikipedia":"https://en.wikipedia.org/wiki/Tisotumab_vedotin","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Tisotumab%20vedotin"}],"tags":[],"related":[],"cancers":["cervical","recurrent-metastatic-cervical-cancer"],"sections":[],"technologies":["adc"],"targets":["tissue-factor"],"drugs":[],"companies":["pfizer","genmab"],"institutions":[],"pathways":[],"terms":["mc-vc-pabc"],"trials":["nct06459180","nct03485209"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Tivdak","modality":"ADC","payload":"MMAE","linker":"mc-vc-PABC","mechanism":"Human anti-tissue-factor IgG1 with MMAE.","approvals":[{"region":"US","year":2021,"indication":"Recurrent/metastatic cervical cancer after chemotherapy (full 2024)"},{"region":"EU","year":2025,"indication":"Recurrent/metastatic cervical after systemic therapy; 28 Mar 2025"}],"mechanismSteps":["Antibody binds Tissue factor on the tumour cell surface","Receptor-ADC complex is internalised by endocytosis","Trafficked to the lysosome; linker is cleaved or antibody degraded","MMAE is released inside the cell","Microtubule assembly is blocked; mitosis arrests","Tumour cell dies by apoptosis","Membrane-permeable payload diffuses to kill neighbouring antigen-negative cells (bystander effect)"],"dosing":{"route":"IV infusion over 30 min","schedule":"2 mg/kg (max 200 mg) every 3 weeks","modifications":"Hold for grade 2 conjunctival changes; discontinue for grade ≥3 corneal events","monitoring":"Ophthalmic exam before first 9 cycles; steroid, vasoconstrictor, and lubricating eye drops; cold packs during infusion","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c9fe3f32-4219-466e-acb9-3f609b4f4df1"},"toxicity":[{"event":"Peripheral neuropathy","anyGradePct":38,"grade3PlusPct":6,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c9fe3f32-4219-466e-acb9-3f609b4f4df1","note":"innovaTV 301, n=250"},{"event":"Conjunctival disorders","anyGradePct":37,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c9fe3f32-4219-466e-acb9-3f609b4f4df1","note":"innovaTV 301, n=250"},{"event":"Nausea","anyGradePct":33,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c9fe3f32-4219-466e-acb9-3f609b4f4df1","note":"innovaTV 301, n=250"},{"event":"Fatigue","anyGradePct":28,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c9fe3f32-4219-466e-acb9-3f609b4f4df1","note":"innovaTV 301, n=250"},{"event":"Epistaxis","anyGradePct":26,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c9fe3f32-4219-466e-acb9-3f609b4f4df1","note":"innovaTV 301, n=250"},{"event":"Alopecia","anyGradePct":24,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c9fe3f32-4219-466e-acb9-3f609b4f4df1","note":"innovaTV 301, n=250"},{"event":"Decreased appetite","anyGradePct":24,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c9fe3f32-4219-466e-acb9-3f609b4f4df1","note":"innovaTV 301, n=250"},{"event":"Haemorrhage","anyGradePct":21,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c9fe3f32-4219-466e-acb9-3f609b4f4df1","note":"innovaTV 301, n=250"},{"event":"Dry eye","anyGradePct":21,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c9fe3f32-4219-466e-acb9-3f609b4f4df1","note":"innovaTV 301, n=250"},{"event":"Corneal complications","grade3PlusPct":3.2,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c9fe3f32-4219-466e-acb9-3f609b4f4df1","note":"innovaTV 301, n=250"}],"access":[{"country":"US","reimbursement":"Medicare Part B (physician-administered); commercial plans per formulary","source":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","asOf":"2026-09-06"},{"country":"UK","reimbursement":"NICE: appraisal for recurrent cervical cancer (2025-26)","source":"https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2021-09-20","type":"accelerated-approval","region":"US","note":"Accelerated approval, recurrent or metastatic cervical cancer after chemotherapy (innovaTV 204)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","indication":"Treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy"},{"date":"2024-04-29","type":"conversion","region":"US","note":"Full approval with OS benefit (innovaTV 301)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","indication":"Treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy"}]},"route":"/drugs/tisotumab-vedotin/","neighbours":{"cancer":[{"id":"cervical","kind":"cancer","name":"Cervical cancer","route":"/cancers/cervical/"},{"id":"recurrent-metastatic-cervical-cancer","kind":"cancer","name":"Recurrent or metastatic cervical cancer","route":"/cancers/recurrent-metastatic-cervical-cancer/"}],"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"}],"target":[{"id":"tissue-factor","kind":"target","name":"Tissue factor","route":"/targets/tissue-factor/"}],"company":[{"id":"genmab","kind":"company","name":"Genmab","route":"/companies/genmab/"},{"id":"pfizer","kind":"company","name":"Pfizer (incl. Seagen)","route":"/companies/pfizer/"}],"term":[{"id":"mc-vc-pabc","kind":"term","name":"mc-Val-Cit-PABC","route":"/terms/mc-vc-pabc/"},{"id":"mmae","kind":"term","name":"MMAE","route":"/terms/mmae/"},{"id":"tubulin-inhibitor-payloads","kind":"term","name":"Tubulin inhibitor payloads","route":"/terms/tubulin-inhibitor-payloads/"}],"trial":[{"id":"nct06459180","kind":"trial","name":"A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With","route":"/trials/nct06459180/"},{"id":"nct03485209","kind":"trial","name":"Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors","route":"/trials/nct03485209/"},{"id":"innovatv-301","kind":"trial","name":"innovaTV 301 / ENGOT-cx12 / GOG-3057","route":"/trials/innovatv-301/"}],"person":[{"id":"bradley-monk","kind":"person","name":"Bradley J. Monk","route":"/people/bradley-monk/"},{"id":"ignace-vergote","kind":"person","name":"Ignace Vergote","route":"/people/ignace-vergote/"}],"paper":[{"id":"paper-innovatv-301-tisotumab-nejm-2024","kind":"paper","name":"innovaTV 301: tisotumab vedotin versus chemotherapy as second- or third-line therapy for recurrent cervical cancer","route":"/key-papers/paper-innovatv-301-tisotumab-nejm-2024/"}],"biomarker":[{"id":"tissue-factor-expression","kind":"biomarker","name":"Tissue factor expression","route":"/biomarkers/tissue-factor-expression/"}]}}