PRAC adopted updates to the SmPC and Package Leaflet for Padcev to support an extension of indication in combination with pembrolizumab for adults with muscle-invasive bladder cancer eligible for cisplatin-containing chemotherapy. (European Medicines Agency) - Aug 31, 2026 - Pharmacovigilance Risk
Assessment Committee (PRAC)-Draft agenda for the meeting on 31 Aug – 3 Sep 2026:
The regimen is used as neoadjuvant treatment and continued as adjuvant
treatment following radical cystectomy, based on the KN-B15 (EV-304) study.
Sections 4.1, 4.2, 4.8 and 5.1 of the SmPC were updated accordingly. [AI
generated summary]
PRAC • Bladder Cancer • Genito-urinary Cancer • Oncology
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