EMA validates Type II variation application for Padcev with Keytruda for first line treatment of advanced Bladder Cancer: Pfizer
Tokyo: Astellas Pharma Inc. and Pfizer Inc. have announced that the European Medicines Agency (EMA) has 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 chemotherapy, the current standard of care in first-line la/mUC," the Company stated.
Ahsan Arozullah, M.D., M.P.H., Senior Vice President, Head of Oncology Development, Astellas said, "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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