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KEYTRUDA Merck Sharp & Dohme (Australia) Pty Ltd
Product name
KEYTRUDA
Accepted date
Jan-2026
Active ingredients
pembrolizumab
Summary of proposed indication
KEYTRUDA (pembrolizumab), in combination with enfortumab vedotin, is proposed for the perioperative treatment of adults with muscle‑invasive bladder cancer (a type of bladder cancer that has grown into the bladder wall) who cannot receive cisplatin‑based chemotherapy. KEYTRUDA can be given before surgery is performed to remove the bladder and then continued after surgery to reduce the risk of the cancer returning
Application type
C (new indication)
Publication date
Jan-2026