EMA Validates Type II Variation Application for PADCEV (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) for 1L Treatment of Advanced Bladder Cancer
Ahsan Arozullah, M.D., M.P.H., Senior Vice President, Head of Oncology Development, Astellas commented, “Patients in Europe need better treatment options for advanced stage urothelial cancer, and we look forward to working with the EMA on their review of the combination of enfortumab vedotin and pembrolizumab. If approved, the combination would be the first alternative to a chemotherapy-based treatment for this patient population. This milestone is another opportunity to affirm our commitment to helping patients with advanced urothelial cancer live longer.”
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