European Medicines Agency Validates Type II Variation Application for PADCEV® (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer | Pfizer
– Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival – – If approved, PADCEV with KEYTRUDA would be the first combination in the EU to offer an alternative to platinum-containing chemotherapy, the current standard of care in first-line locally advanced or metastatic urothelial cancer – 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 KEYTRUDA has the potential to change the treatment paradigm, becoming the first combination treatment to offer an alternative to platinum-containing