EMA Approves Review of Astellas' PADCEV and KEYTRUDA Combination for Bladder Cancer

EMA Review Validation: Astellas Pharma's application for a Type II variation for PADCEV (enfortumab vedotin) has been validated by the European Medicines Agency, seeking approval for its use in combination with KEYTRUDA (pembrolizumab) for treating muscle-invasive bladder cancer (MIBC) patients ineligible for cisplatin-based chemotherapy.

Neoadjuvant and Adjuvant Therapy: The application proposes using the combination therapy as neoadjuvant treatment before radical cystectomy and continuing it as adjuvant therapy post-surgery, aiming to provide more treatment options for MIBC patients.

Clinical Trial Results: The Type II variation application is supported by Phase 3 EV-303 clinical trial results, which demonstrated a 60% reduction in the risk of tumor recurrence, progression, or death, and a 50% reduction in the risk of death, with consistent safety results.

Future Steps: The EMA's Committee for Medicinal Products for Human Use and the European Commission are expected to provide their opinions and decisions on the application by the calendar year 2026.