Astellas Pharma Inc. announced that the European Medicines Agency has validated a Type II variation application for PADCEV, a treatment for muscle-invasive bladder cancer. The application seeks approval for a combination therapy using PADCEV and KEYTRUDA as neoadjuvant and adjuvant treatment for patients ineligible for cisplatin-based chemotherapy. Results from the Phase 3 EV-303 trial showed a 60% reduction in risk of tumor recurrence, progression, or death, and a 50% reduction in risk of death. The EMA is expected to make a decision on the application in 2026. Seagen and Astellas collaborated with Merck for this treatment approach. Pfizer completed its acquisition of Seagen on December 14, 2023.

Read more at Nasdaq: EMA Validates Review Of Astellas’ PADCEV And KEYTRUDA Combination In Bladder Cancer