Tisotumab vedotin (recurrent/metastatic cervical cancer 2L+, innovaTV 204 / innovaTV 301)
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
Knowledge-base record for audit. Provisional clinical content: this is not a prescription. An oncologist must verify original sources, applicability and review status. Full rules and constraints are in the YAML.
| Components | DRUG-TISOTUMAB-VEDOTIN |
|---|
| ID | REG-TISOTUMAB-VEDOTIN-CERVICAL-2L |
|---|---|
| Type | Regimen |
| Status | reviewed 2026-04-29 | pending_clinical_signoff |
| Diseases | None declared |
| Sources | SRC-ESMO-CERVICAL-2024 SRC-NCCN-CERVICAL-2025 |
Notes
First and only ADC approved for recurrent / metastatic cervical cancer 2L+ post-platinum (with or without bevacizumab + pembrolizumab in 1L per CPS). Pivotal innovaTV 204 (Coleman Lancet Oncol 2021, n=101): ORR 24%, mDOR 8.3 mo, mPFS 4.2 mo, mOS 12.1 mo → FDA accelerated approval Sep 20, 2021. Confirmatory innovaTV 301 (Vergote NEJM 2024, n=502, tisotumab vedotin vs investigator-choice chemo): mOS 11.5 vs 9.5 mo (HR 0.70, p=0.0038), mPFS 4.2 vs 2.9 mo (HR 0.67), ORR 17.8% vs 5.2% → FDA full approval Apr 29, 2024. Mandatory baseline ophthalmologic exam + per-cycle exams for first 9 cycles. No companion biomarker required (TF broadly expressed on cervical carcinoma). Bibliographic record SRC-INNOVATV-204 (Coleman 2021) is available; SRC-INNOVATV-301 and SRC-FDA-TIVDAK remain source gaps. Clinical claim linkage requires review.
Used By
Indication
IND-CERVICAL-2L-TISOTUMAB-VEDOTIN- IND-CERVICAL-2L-TISOTUMAB-VEDOTIN