FDA Grants Full Approval for TIVDAK® to Treat Recurrent or Metastatic Cervical Cancer | Pfizer
TIVDAK is the first antibody-drug conjugate (ADC) to have positive overall survival data for patients with previously treated recurrent or metastatic cervical cancer Conversion to full approval from accelerated approval is based on positive results from global Phase 3 study demonstrating overall survival benefit of TIVDAK compared to chemotherapy Pfizer Inc. (NYSE: PFE) and Genmab A/S (Nasdaq: GMAB) today announced the U.S. Food and Drug Administration (FDA) approves 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. “Recurrent or metastatic cervical cancer is a particularly devastating and mostly incurable disease, and patients are in need of survival-extending treatment options,” said Chris Boshoff, M.D., Ph.D., Chief Oncology Officer, Executive Vice President at Pfizer. “Today’s full approval by