CHMP adopted a positive opinion recommending use of pembrolizumab plus enfortumab vedotin as perioperative therapy for cisplatin-ineligible resectable muscle-invasive bladder cancer, covering neoadjuvant treatment before surgery and adjuvant therapy afterwards.

In the Phase 3 KEYNOTE-905 trial, the regimen reduced risk of event-free survival events by 60% (HR = 0.40; p < 0.0001) and risk of death by 50% (HR = 0.50; p = 0.0002) versus surgery alone, achieved a 57.1% pathologic complete response rate versus 8.6%, and did not reach median EFS compared to 15.7 months for surgery alone.

The positive opinion will be reviewed by the European Commission, with a final marketing decision expected by Q3 2026 for the EU, Iceland, Liechtenstein and Norway, potentially expanding options for the roughly 25% of bladder cancer patients with muscle-invasive disease who are ineligible for cisplatin.