BRIEF—Keytruda combo sBLA gains priority review from FDA

The US Food and Drug Administration has accepted for review a supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab), Merck & Co’s anti-PD-1 therapy, based on results of the Phase III KEYNOTE-189 trial.

The application seeks approval for Keytruda in combination with pemetrexed (Alimta) and platinum chemotherapy (carboplatin or cisplatin) as a first-line treatment for patients with metastatic non-squamous non-small cell lung cancer (NSCLC). The FDA has granted Priority Review to this sBLA and has set a Prescription Drug User Fee Act (PDUFA), or target action, date of September 23, 2018.

“Keytruda is the first immunotherapy to significantly extend survival of patients with non-squamous non-small cell lung cancer in combination with chemotherapy as a first-line treatment, including in patients whose tumors are either PD-L1 negative or are untested,” said Dr Roger Perlmutter, president, Merck Research Laboratories, adding: “With this sBLA acceptance by the FDA, we are pleased that data from KEYNOTE-189 is now under review by regulatory authorities in the United States, Europe, and Japan.”