TIVDAK® (tisotumab vedotin-tftv) Receives U.S. FDA Approval to Treat Recurrent or Metastatic Cervical Cancer
Genmab A/S - American Depositary Shares (GMAB)
Company Research
Source: Business Wire
Company AnnouncementFull approval based on global Phase 3 study demonstrating overall survival benefit of TIVDAK compared to chemotherapyTIVDAK is the first antibody-drug conjugate in this patient population to have positive overall survival data COPENHAGEN, Denmark--(BUSINESS WIRE)--Genmab A/S (Nasdaq: GMAB) and Pfizer Inc. (NYSE: PFE) announced today the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TIVDAK® (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. This FDA action converts the September 2021 accelerated approval of TIVDAK to a full approval. TIVDAK is the first antibody-drug conjugate (ADC) with demonstrated overall survival data to be granted full FDA approval in this patient population.The approval is based on results from the global, randomized, Phase 3 innovaTV 301 clinical trial (NCT04697628), in which T
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