Merck: FDA grants priority review to sBLA for Keytruda plus chemotherapy

Merck announced the U.S. FDA has accepted for priority review a new supplemental Biologics License Application seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (carboplatin and paclitaxel), followed by KEYTRUDA as a single agent for the treatment of patients with primary advanced or recurrent endometrial carcinoma. The FDA has set a Prescription Drug User Fee Act, or target action, date of June 21, 2024.