9 January 2024 - Submission based on positive results from global Phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy.
Pfizer and Genmab announced today that the US FDA has accepted the supplemental biologics license application seeking to convert the accelerated approval of Tivdak (tisotumab vedotin-tftv) to full approval, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy.