medwireNews: The US FDA has approved pembrolizumab for the treatment of high-risk, non-muscle invasive bladder cancer (NMIBC) that is unresponsive to Bacillus Calmette-Guérin (BCG).
The PD-1 inhibitor is indicated for patients who have carcinoma in situ (CIS), with or without papillary tumors, who are not candidates for cystectomy.
The FDA based its decision on the findings of the phase 2 KEYNOTE-057 trial, which showed a complete response rate of 41% among 96 participants with BCG-unresponsive NMIBC with CIS, where a complete response was defined as negative results on cystoscopy. The median duration of response was 16.2 months.
Pembrolizumab should be administered at the standard dose of 200 mg every 3 weeks.
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