European Commission Approves Astellas' PADCEV™ (enfortumab vedotin) in Combination with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Urothelial Cancer [Yahoo! Finance]
ASTELLAS PHARMA UNSP/ADR (ALPMY)
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Source: Yahoo! Finance
- European Marketing Authorization based on positive overall survival and progression-free survival results from the global Phase 3 EV-302 trial TOKYO Aug. 28, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura , "Astellas") today announced that the European Commission has granted Marketing Authorization for PADCEV™ (enfortumab vedotin, an antibody-drug conjugate [ADC]) in combination with KEYTRUDA ® (pembrolizumab, a PD-1 inhibitor) for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer, who are eligible for platinum-containing chemotherapy. The approval is based on results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) which showed that enfortumab vedotin in combination with pembrolizumab nearly doubled median overall survival (OS) and significantly extended progression-free survival (PFS) compared to platinum-containing chemotherapy Dr. Thomas Powles , Barts Cancer Institute Bio
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