EU CHMP Adopts Positive Opinion Recommending Approval Of KEYTRUDA, Merck’s Anti-PD-1 Therapy, In Combination With Padcev As Neoadjuvant Treatment For Adults With Resectable Muscle-Invasive Bladder Cancer

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Merck's KEYTRUDA in combination with Padcev for the treatment of adults with resectable muscle-invasive bladder cancer (MIBC). This recommendation is based on positive results from the Phase 3 KEYNOTE-B15 trial, which showed improvements in event-free survival, overall survival, and pathologic complete response rates. If approved, this regimen would be the first PD-1 inhibitor plus antibody-drug conjugate treatment for MIBC patients in the EU, with a final decision from the European Commission expected by the fourth quarter of 2026.