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European Medicines Agency Validates Type II Variation Application for PADCEV® (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer
PFEPfizer(PFE) Businesswire·2024-01-26 17:00

NEW YORK & TOKYO--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) today announced that on January 26 the European Medicines Agency (EMA) validated for review a Type II variation application for PADCEV® (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). If approved, PADCEV with K ...