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EMA Validates Application for First-Line Enfortumab Vedotin Plus Pembrolizumab in Urothelial Cancer

The type II variation application for enfortumab vedotin plus pembrolizumab in untreated metastatic urothelial cancer has been validated by the EMA.

EMA to reciew Pfizer-Astellas' application for bladder cancer therapy

The EMA has validated for review a Type II variation application for Pfizer and Astellas Pharma’s PADCEV combination regimen for urothelial cancer.

Pfizer (PFE) Announces EMA Validates Type II Variation Application for PADCEV with KEYTRUDA for First-Line Treatment of Advanced Bladder Cancer

European Medicines Agency Validates Type II Variation Application for PADCEV® (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer

European Medicines Agency Validates Type II Variation Application for PADCEV™ (enfortumab vedotin) with KEYTRUDA®(pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer

/PRNewswire/ Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. (NYSE: PFE) today announced that on Jan. 26, 2024.