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drugsProductApproved2021🇪🇺🇬🇧🇯🇵

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.

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Payload: MMAE · 2D coordinates (no PubChem conformer)
PubChem
How it works, step by step · animated schematic, not to scale
Antibody-drug conjugate (ADC)
Mechanism, step by step
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1.Antibody binds Tissue factor on the tumour cell surface

Modality
ADC
Mechanism
Human anti-tissue-factor IgG1 with MMAE.
Brand / code
Tivdak
Payload
MMAE
Linker
mc-vc-PABC
Dosing & schedule
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

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.

Not yet researchedSearch NICE
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.

Regulatory

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  1. 20 Sept 2021ApprovalUS

    Accelerated approval, recurrent or metastatic cervical cancer after chemotherapy (innovaTV 204) source

  2. 29 Apr 2024ApprovalUS

    Full approval with OS benefit (innovaTV 301) source

Approvals

RegionYearIndication
US2021Recurrent/metastatic cervical cancer after chemotherapy (full 2024)

Safety

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Toxicity profile
Adverse eventAny gradeGrade 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.

Cost & access

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Cost & access
CountryReimbursement
United StatesMedicare Part B (physician-administered); commercial plans per formulary
United KingdomNICE: appraisal for recurrent cervical cancer (2025-26)

List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
11 studies0 recruiting9 Phase 22 Phase 3
Search “Tisotumab vedotin” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Tisotumab vedotin
intervention: Tisotumab vedotin
Open on ClinicalTrials.gov →

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Latest papers

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Literature trend37 papers in the last 12 months+19% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

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.

Connected

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