FDA converts tisotumab vedotin’s accelerated approval to full approval for recurrent or metastatic cervical cancer

High-Certainty EvidenceFDA-approved for the exact stated cancer/useNot addressed

The FDA granted full (traditional) approval to tisotumab vedotin-tftv (Tivdak), an antibody-drug conjugate directed at tissue factor, for adults with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy — converting the drug’s original September 2021 accelerated approval, which had been based on earlier, single-arm trial data, into a full approval. The conversion was supported by the randomized, open-label, phase 3 innovaTV 301 trial (ClinicalTrials.gov NCT04697628; results reported in Annals of Oncology, DOI 10.1016/j.annonc.2023.10.029), which enrolled 502 patients with recurrent or metastatic cervical cancer who had received one or two prior systemic regimens. Patients randomized to tisotumab vedotin had a median overall survival of 11.5 months versus 9.5 months with chemotherapy (hazard ratio 0.70; P=0.0038) and a median progression-free survival of 4.2 months versus 2.9 months (hazard ratio 0.67; P<0.0001) — both statistically significant improvements over chemotherapy.

What This Means

In the randomized, open-label, phase 3 innovaTV 301 trial, tisotumab vedotin significantly extended both overall survival (11.5 months versus 9.5 months) and progression-free survival (4.2 months versus 2.9 months), compared with chemotherapy, in patients with previously-treated recurrent or metastatic cervical cancer. This confirmatory result converted the drug's original 2021 accelerated approval into a full, traditional FDA approval — a meaningfully higher evidentiary bar than the single-arm data the original approval rested on.

What This Doesn't Mean

This approval is specifically for patients whose cervical cancer has recurred or spread and who have already tried chemotherapy — it is not a first-line or preventive therapy, and does not apply to cervical cancer that has not yet progressed on prior treatment.

Why It Matters

A statistically significant overall-survival benefit in a randomized, confirmatory phase 3 trial, converting an accelerated approval to full approval, represents real, mature, high-confidence evidence for a cancer type with historically limited options once chemotherapy stops working.

Promise & Proof

Proof — strength of the evidence 5 / 5

Base score from evidence stage: High-Certainty Evidence.
FDA-approved for the exact stated cancer/use.

Promise — potential significance if later evidence holds up 3 / 5

Baseline — a validly-evidenced story starts here; every further point below is an explicit, checkable reason.
The record includes substantive editorial reasoning about why this discovery matters.
A distinct follow-on/confirmatory study or trial is already cited as a secondary source — the field is already building on this finding.

These two ratings are automatically computed from this story's own structured evidence fields and are shown separately on purpose — they are never combined into one score. They describe this record, not a medical recommendation: they do not establish medical certainty, do not substitute for reading the cited sources, and are recalculated whenever the underlying evidence changes.

Population / Applicability

Studied in: Adults with recurrent or metastatic cervical cancer who had received one or two prior systemic regimens (including chemotherapy, with or without bevacizumab or an anti-PD-(L)1 agent), randomized to tisotumab vedotin or investigator's choice of chemotherapy. (Adults)

Antibody-drug conjugates including tisotumab vedotin carry known risks (including ocular toxicity, requiring an eye-care monitoring program) that must be disclosed as part of counseling — this record does not itself detail the full safety profile and that should be added before publication.

Full evidence details

Study design: Randomized controlled trial
Sample size: 502

Funding & Conflicts

Co-developed by Genmab and Seagen; Pfizer inherited the drug following its 2023 acquisition of Seagen — not independently confirmed against a primary corporate-disclosure document.

Regulatory status by jurisdiction

United States (FDA)

Status: FDA-approved for the exact stated cancer/use
Indication: Adults with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
Decision date: 2024-04-29
Source: Regulator record (opens in a new tab)

Guideline positions

Guideline

Position: Not addressed
Last verified: 2026-08-13

Primary evidence supporting this story

innovaTV 301/ENGOT-cx12/GOG-3057 trial results: tisotumab vedotin versus chemotherapy in recurrent or metastatic cervical cancer (Annals of Oncology) (opens in a new tab) (Peer-reviewed paper) [Peer-reviewed] 10.1016/j.annonc.2023.10.029 Load-bearing source DOI 10.1016/j.annonc.2023.10.029
innovaTV 301/ENGOT-cx12/GOG-3057 trial results: tisotumab vedotin versus chemotherapy in recurrent or metastatic cervical cancer (Annals of Oncology). DOI 10.1016/j.annonc.2023.10.029.

Additional context

innovaTV 301/ENGOT-cx12/GOG-3057 trial registry (opens in a new tab) (Clinical-trial registry) NCT04697628 NCT04697628
innovaTV 301/ENGOT-cx12/GOG-3057 trial registry. NCT04697628.

Why Should I Trust This?

1 source at Tier 2 — Peer-reviewed primary research, trial registries, regulatory documents, official conference abstracts
Last reviewed: 2026-08-13

This panel summarizes real, checkable facts about this record's own sources and review status — it is not a trust score, and reading it is not a substitute for reading the cited sources yourself.

Discovery Timeline

Every recorded change to this record's content or publication status, in order.

2026-08-13 Status change — Status changed from "Legacy / Unverified" to "In editorial review".
2026-08-13 Status change — Status changed from "In editorial review" to "Verified".

Last reviewed 2026-08-13