European Commission approves Keytruda-Padcev for bladder cancer surgery patients

The European Commission has approved Keytruda in combination with Padcev for adults with resectable muscle-invasive bladder cancer who cannot take cisplatin, giving oncologists a new perioperative option for a patient group that has long had limited chemotherapy choices before cystectomy. The label covers treatment before surgery and continuation after radical cystectomy, a sequence that could change both when therapy starts and how much treatment patients receive around an operation that is still meant to be curative.

The decision followed a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use on May 21, 2026, and Merck highlighted the recommendation the next day. Astellas Pharma, which markets Padcev with Merck’s Keytruda, said the approval makes the regimen the first and only approved perioperative treatment option in the European Union for cisplatin-ineligible patients with resectable muscle-invasive bladder cancer. That status matters in a disease where cisplatin ineligibility often shuts patients out of standard platinum-based chemotherapy at the exact point when earlier treatment can matter most.

Merck said the approval rests on phase 3 KEYNOTE-905 results showing a 60% reduction in event-free survival events and a 50% reduction in the risk of death versus surgery alone, along with a 48% increase in pathologic complete response rate. ESMO said the KEYNOTE-905 and EV-303 data were statistically significant and clinically meaningful and could represent a potential new standard of care for cisplatin-ineligible patients with muscle-invasive bladder cancer. For patients facing radical cystectomy, that means the treatment pathway can now include both neoadjuvant immunotherapy and antibody-drug conjugate therapy, then adjuvant continuation after surgery, rather than surgery alone.

The European action also lands in a wider regulatory race. The FDA approved the same perioperative combination on November 21, 2025, and NCCN’s 2026 bladder cancer guideline page shows the field is still being actively updated as clinicians reassess earlier-stage bladder cancer treatment. Merck and Astellas have also been pushing the same drug pair into other muscle-invasive bladder cancer settings, including cisplatin-eligible disease, which raises the chance that reimbursement debates and standard-of-care discussions will extend beyond Europe as hospitals, insurers and guideline panels weigh where the regimen fits best.