FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) in certain patients with high-risk, non-muscle invasive bladder cancer (NMIBC)


2 December 2019 - Application based on results from Phase 2 KEYNOTE-057 trial, to be discussed at December FDA Oncologic Drugs Advisory Committee meeting.

Merck today announced that the U.S. FDA has accepted and granted priority review for a new supplemental biologics license application for Keytruda, Merck’s anti-PD-1 therapy. The application seeks approval of Keytruda 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 tumours who are ineligible for or have elected not to undergo cystectomy (removal of bladder). 

This application for Keytruda, which is based on results from the Phase 2 KEYNOTE-057 trial, will be discussed at the Dec. 17 meeting of the FDA’s Oncologic Drugs Advisory Committee. Data from this trial were first presented at the European Society for Medical Oncology 2018 Congress. Merck anticipates a Prescription Drug User Fee Act, or target action date, in January 2020, based on priority review.

Read Merck press release

Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Priority review