Policy & Regulation
US FDA grants Merck's Keytruda priority review
3 December 2019 -

The US Food and Drug Administration (FDA) has granted priority review to United States-based Merck for its anti-PD-1 therapy Keytruda in certain patients with high-risk, non-muscle invasive bladder cancer (NMIBC), it was reported yesterday.

The new supplemental Biologics License Application (sBLA) for the product, which has been accepted by the US FDA, is for the treatment of patients having Bacillus Calmette-Guerin (BCG) -unresponsive, high-risk, NMIBC. Through the application, the company is looking for approval for the treatment of the condition in patients with carcinoma in-situ (CIS) irrespective of papillary tumours who are not eligible for or have decided not to have their bladder removed.

The sBLA is based on the data from the phase two KEYNOTE-057 trial, which were showcased first at the European Society for Medical Oncology 2018 Congress. The company expects a Prescription Drug User Fee Act or target action date for the anti-PD-1 therapy for the new indication in January 2020.

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