Merck says EU CHMP backs Keytruda-Padcev perioperative use in resectable muscle-invasive bladder cancer

EU regulators issued a positive CHMP opinion; European Commission decision is expected in Q4 2026.

U.S. regulators cleared the regimen in July 2026, positioning it as a key growth driver across earlier-stage bladder cancer.

Merck says EU CHMP backs Keytruda-Padcev perioperative use in resectable muscle-invasive bladder cancer.

Merck reported Phase 3 KEYNOTE-B15 results supporting perioperative Keytruda with Padcev in resectable muscle-invasive bladder cancer. Results were already reported in the CHMP briefing; no future scientific meeting presentation was specified.

The trial showed fewer disease events and longer survival versus standard neoadjuvant chemotherapy followed by surgery.