The European Medicines Agency's Committee for Medicinal Products for Human Use recommended approving PADCEV in combination with Merck's Keytruda.
The regimen targets perioperative treatment for adults with cisplatin-ineligible resectable muscle-invasive bladder cancer.
Astellas and Seagen co-developed PADCEV. Pfizer acquired Seagen in 2023.
The Phase 3 EV-303 trial supports the recommendation. The trial demonstrated a 60% reduction in the risk of disease recurrence, progression, or death compared to surgery alone.
The combination also lowered the risk of death by 50%.
The European Commission anticipates a final approval decision by the third quarter of 2026.