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Drugs & Targets

FDA grants Priority Review to Merck’s Supplemental Biologics License Application for Keytruda in NMIBC indication

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FDA has granted priority review for a new supplemental Biologics License Application for Keytruda, which seeks approval of the anti-PD-1 therapy as monotherapy in patients with Bacillus Calmette-Guerin-unresponsive, 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.

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