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MSD's Keytruda chalks up bladder cancer approval in the US

Published on 09/01/20 at 12:14pm

MSD’s blockbuster immunotherapy Keytruda (pembrolizumab) has added another US approval to its repertoire with the news that FDA has awarded marketing authorisation to the therapy for the treatment of a specific form of bladder cancer.

Specifically, the ruling was made in regard to patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours who are ineligible for or have elected not to undergo cystectomy.

Data from 148 patients provided in support of the application illustrated that 41% of the 96 patients with high-risk BCG-unresponsive NMIBC with CIS experienced a complete response, as defined by negative results for cystoscopy, urine cytology, and computed tomography urography imaging – one of the study’s primary endpoints.  

The other primary endpoint of the study, duration of response, was measured at a median of 16.2 months, with 46% of patients’ responses lasting at least 12 months.

Matt Fellows

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