FDA acepts SBLA for Keytruda + Alimta and chemotherapy to treat metastatic nonsquamous NSCLC.- Merck Inc.

Merck INc., has announced that the FDA has accepted for review a supplemental Biologics License Application (sBLA) for Keytruda, the company�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 nonsquamous 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 23 September 2018.

This supplemental application is based on overall survival (OS) and progression-free survival (PFS) data from the Phase III KEYNOTE-189 trial, which were recently presented at the American Association of Cancer Research (AACR) 2018 Annual Meeting, and published simultaneously in The New England Journal of Medicine. KEYNOTE-189 is the confirmatory trial for KEYNOTE-021 (Cohort G), a Phase II study that made Keytruda the only FDA-approved anti-PD-1 therapy in combination with chemotherapy (pemetrexed plus carboplatin) for the first-line treatment of patients with metastatic nonsquamous NSCLC, regardless of PD-L1 expression. If approved by the FDA, this would mark the third indication for Keytruda in metastatic NSCLC in the United States based on OS data.