CHMP adopted a request for supplementary information with a specific timetable for the extension application for Keytruda in combination with enfortumab vedotin as neoadjuvant treatment followed by adjuvant treatment after radical cystectomy in adults with MIBC who are ineligible for cisplatin-containing chemotherapy. (European Medicines Agency) - Aug 30, 2026 - CHMP Final
Minutes of the meeting on 23 - 26 Feb 2026: The application is supported
by interim results from the open-label, randomized, Phase 3 KEYNOTE-905 study
and proposes updates to SmPC sections 4.1, 4.2, 4.8 and 5.1. [AI generated
summary]
CHMP • Bladder Cancer • Genito-urinary Cancer • Oncology
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