TIVDAK® (tisotumab vedotin-tftv) Receives U.S. FDA Approval to Treat Recurrent or Metastatic Cervical Cancer
This FDA action converts the September 2021 accelerated approval of TIVDAK to a full approval.
- This FDA action converts the September 2021 accelerated approval of TIVDAK to a full approval.
- TIVDAK is the first antibody-drug conjugate (ADC) with demonstrated overall survival data to be granted full FDA approval in this patient population.
- The approval is based on results from the global, randomized, Phase 3 innovaTV 301 clinical trial ( NCT04697628 ), in which TIVDAK met its primary endpoint of overall survival (OS) in patients with previously treated recurrent or metastatic cervical cancer compared to chemotherapy.
- “Treatment options for patients with advanced or recurrent cervical cancer are limited.