The FDA on Wednesday said it approved Merck & Co.'s filing for Keytruda (pembrolizumab) for patients with Bacillus Calmette-Guérin (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 decided not to undergo cystectomy. The decision follows a recent FDA advisory committee voting in favour of expanding the anti-PD-1 therapy's label to include use in this indication.
Scot Ebbinghaus, vice president of clinical research at Merck Research Laboratories, noted that "as the first anti-PD-1 therapy approved in this setting, Keytruda will be a new clinical option for a patient population that previously had limited FDA-approved therapies available."
The agency said efficacy was assessed in the Phase II KEYNOTE-057 trial, which enrolled 148 patients with high-risk NMIBC, 96 of whom had BCG-unresponsive CIS, with or without papillary tumours. The complete response rate in the 96 patients was 41%, while the median response duration was 16.2 months. The FDA noted that 46% of responding patients experienced a complete response lasting at least 12 months.
The agency cleared Keytruda in 2017 for certain patients with locally advanced or metastatic urothelial carcinoma in both the first- and second-line settings.
In November last year, a new joint venture between Ferring Pharmaceuticals and Blackstone Life Sciences reported that the experimental gene therapy nadofaragene firadenovec had met the primary endpoint of a Phase III study, with over half of patients with high-grade, BCG-unresponsive NMIBC achieving a complete response at three months.
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