Astellas Submits Supplemental New Drug Application in Japan for PADCEV (Enfortumab Vedotin) + Keytruda (Pembrolizumab) for Muscle-Invasive Bladder Cancer
Astellas Pharma submitted a Supplemental New Drug Application (sNDA) in Japan on January 30, 2026, for PADCEV (enfortumab vedotin) combined with Keytruda (pembrolizumab) for certain patients with muscle-invasive bladder cancer (MIBC).
This submission advances the role of antibody-drug conjugates (ADCs) in earlier-stage bladder cancer treatment.
The application targets expansion to cisplatin-eligible patients, building on prior approvals for cisplatin-ineligible MIBC.
Related global developments include FDA Priority Review (target action date August 17, 2026) for perioperative use regardless of cisplatin eligibility based on EV-304 trial data showing 47% reduction in risk of recurrence/progression/death.
EMA validated a Type II Variation Application on December 1, 2025, for similar expansion in Europe.