The FDA grants Priority Review status to Merck’s (NYSE:MRK) supplemental marketing application seeking approval to use Keytruda (pembrolizumab) to treat patients with high-risk non-muscle invasive bladder cancer with carcinoma in-situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy (removal of bladder) and who have failed to respond to standard-of-care Bacillus Calmette-Guerin therapy.
The agency’s action date should be next month.
Shares up 1% premarket on light volume.
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