Posted by Michael Wonder on 30 Nov 2023
FDA grants priority review for supplemental biologics license application of Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) for first-line treatment of advanced bladder cancer
30 November 2023 - Results of pivotal confirmatory trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall survival and progression-free survival vs standard platinum containing chemotherapy.
Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") and Seagen Inc. (Nasdaq: SGEN) today announced that on November 30, 2023 the U.S. Food and Drug Administration (FDA) accepted for priority review a supplemental Biologics License Application (sBLA) for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) as a combination therapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
