Merck Gets FDA Priority Review for Keytruda in High-Risk, Non-Muscle Invasive Bladder Cancer

By Colin Kellaher

Merck & Co. (MRK) on Monday said the U.S. Food and Drug Administration granted priority review to its supplemental biologics license application for Keytruda in a form of bladder cancer.

The Kenilworth, N.J., drug maker said the sBLA seeks accelerated approval of the cancer drug as monotherapy for the treatment of 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 removal of bladder.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.

Merck said the FDA's advisory committee on oncologic drugs will discuss the application at its Dec. 17, adding that it expects an FDA target action date in January.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

December 02, 2019 07:10 ET (12:10 GMT)

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