FDA Grants Full Approval for TIVDAK® to Treat Recurrent or Metastatic Cervical Cancer [Yahoo! Finance]
Genmab A/S - American Depositary Shares (GMAB)
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Source: Yahoo! Finance
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 NEW YORK & COPENHAGEN, Denmark, April 29, 2024 BUSINESS WIRE 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 the FDA reinforces the important role of TIVDAK for these patients, as the first antibody-drug conj
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