Genmab-Pfizer gain full FDA approval for TIVDAK in Metastatic Cervical Cancer

Pfizer (PFE) and Genmab A/S (GMAB) “announced the FDA approves the supplemental Biologics License Application granting full approval for TIVDAK, or 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, which met its primary endpoint, demonstrating overall survival benefit in adult patients with previously treated recurrent or metastatic cervical cancer treated with TIVDAK compared to chemotherapy. Secondary endpoints of progression-free survival (PFS) and confirmed objective response rate were also met. In October 2023, results from the innovaTV 301 study were presented during the Presidential session at the European Society of Medical Oncology Congress. The innovaTV 301 study demonstrated a 30% reduction in the risk of death compared to chemotherapy. Median OS for patients treated with TIVDAK was 11.5 months versus chemotherapy 9.5 months.”