Tisotumab vedotin
Tisotumab vedotin is an ADC against tissue factor, the first to show a survival benefit in recurrent cervical cancer.
innovaTV 301: OS 11.5 vs 9.5 months versus chemotherapy in second/third-line cervical cancer; full approval 2024. Ocular and bleeding events are notable.
1.Antibody binds Tissue factor on the tumour cell surface
- Route
- IV infusion over 30 min
- Schedule
- 2 mg/kg (max 200 mg) every 3 weeks
- Dose 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: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
- Medicare
- Part B (clinician-administered)
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.
- Commercial insurance
- covered with prior authorisation
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.
- Assistance programmes
- Seagen Secure (Pfizer)
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
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.
- Notes
- MHRA-licensed 2025 for recurrent or metastatic cervical cancer; NICE appraisal in progress. Check NICE.
Sources: NICE search: tisotumab vedotin. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- 20 Sept 2021ApprovalUS
Accelerated approval, recurrent or metastatic cervical cancer after chemotherapy (innovaTV 204) source
- 29 Apr 2024ApprovalUS
Full approval with OS benefit (innovaTV 301) source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2021 | Recurrent/metastatic cervical cancer after chemotherapy (full 2024) |
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery 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.
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