Tisotumab vedotin is an ADC against tissue factor, the first to show a survival benefit in recurrent cervical cancer.
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.
Ball-and-stick model from PubChem 2D record (no 3D conformer available). PubChem record
Human anti-tissue-factor IgG1 with MMAE. Connects to Tissue factor.
1.Antibody binds Tissue factor on the tumour cell surface
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies.
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE TA1164. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
| Date | Deal | Type | Upfront | Total | Source |
|---|---|---|---|---|---|
| 2023-03-13 | Seagen to Pfizer (incl. Seagen) Padcev, Tivdak, Adcetris, Tukysa and the vedotin ADC platform | Acquisition | not disclosed | $43bn | source |
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Treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
Accelerated approval, recurrent or metastatic cervical cancer after chemotherapy (innovaTV 204) source
Treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
Full approval with OS benefit (innovaTV 301) source
| Region | Year | Indication |
|---|---|---|
| US | 2021 | Recurrent/metastatic cervical cancer after chemotherapy (full 2024) |
| EU | 2025 | Recurrent/metastatic cervical after systemic therapy; 28 Mar 2025 |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Peripheral neuropathy | 38% | 6% |
| Conjunctival disorders | 37% | - |
| Nausea | 33% | - |
| Fatigue | 28% | - |
| Epistaxis | 26% | - |
| Alopecia | 24% | - |
| Decreased appetite | 24% | - |
| Haemorrhage | 21% | - |
| Dry eye | 21% | - |
| Corneal complications | - | 3.2% |
innovaTV 301, n=250. Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (physician-administered); commercial plans per formulary | not disclosed | - |
| United Kingdom | NICE: appraisal for recurrent cervical cancer (2025-26) | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Query for this drug: (TITLE:"Tisotumab vedotin" OR ABSTRACT:"Tisotumab vedotin" OR TITLE:"Tivdak" OR ABSTRACT:"Tivdak") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Tisotumab vedotin, not a curated reading list.
Shares mc-Val-Cit-PABC, MMAE, Tubulin inhibitor payloads, Antibody-drug conjugate (ADC).
Shares mc-Val-Cit-PABC, MMAE, Tubulin inhibitor payloads, Antibody-drug conjugate (ADC).
Shares Recurrent or metastatic cervical cancer, Cervical cancer, Antibody-drug conjugate (ADC).
Shares Bradley J. Monk, Recurrent or metastatic cervical cancer, Cervical cancer.
Shares Recurrent or metastatic cervical cancer, Cervical cancer, Antibody-drug conjugate (ADC).
Shares MMAE, Tubulin inhibitor payloads, Antibody-drug conjugate (ADC).
Shares Recurrent or metastatic cervical cancer, Cervical cancer, Antibody-drug conjugate (ADC).
Shares MMAE, Tubulin inhibitor payloads, Antibody-drug conjugate (ADC).