Extension of indication to include Padcev, in combination with pembrolizumab, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adults with muscle invasive bladder cancer who are eligible for cisplatin-containing chemotherapy, based on KN-B15. (European Medicines Agency) - Sep 6, 2026 - Pharmacovigilance Risk
Assessment Committee (PRAC) Minutes of meeting on 8 – 11 Jun 2026: As
consequence, sections 4.1, 4.2, 4.8, and 5.1 of the SmPC have been updated; the
Package Leaflet is updated accordingly. Version 6.1 of the RMP is submitted, to
reflect the updated data. [AI generated summary]
PRAC • Bladder Cancer • Genito-urinary Cancer • Oncology
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