FDA grants Priority Review for TIVDAK supplemental BLA for cervical cancer
The U.S. Food and Drug Administration (FDA) has accepted Pfizer and Genmab's supplemental Biologics License Application (sBLA) for TIVDAK® (tisotumab vedotin-tftv) for Priority Review. The application seeks to convert the drug's accelerated approval to full approval.
Pfizer Inc. and Genmab A/S announced that the U.S. Food and Drug Administration (FDA) has accepted their supplemental Biologics License Application (sBLA) for TIVDAK® (tisotumab vedotin-tftv) for Priority Review. The submission seeks to convert the drug's existing accelerated approval to full approval for the treatment of patients with recurrent or metastatic cervical cancer who have experienced disease progression on or after first-line therapy.
The application is supported by efficacy and safety data from the global Phase 3 innovaTV 301 trial. This study demonstrated that TIVDAK significantly improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) compared to chemotherapy in patients with previously treated recurrent or metastatic cervical cancer. The safety profile observed in the trial was consistent with the known safety profile of TIVDAK.
TIVDAK originally received accelerated approval in the U.S. in September 2021, based on data from the Phase 2 innovaTV 204 trial. The data from the Phase 3 innovaTV 301 study will also be used to support global regulatory submissions.
Cervical cancer, particularly in its recurrent or metastatic forms, represents a significant unmet medical need. TIVDAK offers a potential new treatment option for patients with limited therapeutic choices.