Merck wins EU CHMP backing for Keytruda-Padcev in cisplatin-ineligible bladder cancer

Merck & Co., Inc.

Merck & Co., Inc.

MRK

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  • EU drug regulators issued a positive CHMP opinion for Keytruda with Padcev as perioperative therapy for cisplatin-ineligible adults with resectable muscle-invasive bladder cancer.
  • The European Commission is reviewing the filing for marketing authorization in the EU, Iceland, Liechtenstein, and Norway, with a decision expected in Q3 2026.
  • The recommendation was supported by Phase 3 KEYNOTE-905 data showing event-free survival hazard ratio 0.40, overall survival hazard ratio 0.50.


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