Pfizer Inc. and Genmab A/S announced the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) granting full approval for TIVDAK®? (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The approval is based on results from the global, randomized, Phase 3 innovaTV 301 clinical trial (NCT04697628), which met its primary endpoint, demonstrating overall survival (OS) benefit in adult patients with previously treated recurrent or metastatic cervical cancer treated with TIVDAK compared to chemotherapy.

The sBLA application received a Priority Review Designation, which is granted by the FDA to medicines that may offer significant advances in treatment or may provide a treatment where no adequate therapy exists. TIVDAK was originally granted accelerated approval in the U.S. by the FDA in September 2021, based on tumor response and durability of response from the innovaTV 204 pivotal Phase 2 single-arm clinical trial evaluating TIVDAK in patients with previously treated recurrent or prostate cancer. The FDA's approval of the sBLA converts the accelerated approval for TIVDAK to full approval in the U.S".