Merck Submits Supplemental Biologics License Application FDA for Keytruda (Pembrolizumab) in Advanced NSCLC

Merck (MSD outside the US Canada) has submitted a supplemental Biologics License Application to FDA for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of advanced non-small cell lung cancer (NSCLC). KEYTRUDA previously received Breakthrough Therapy designation for advanced NSCLC and this initial filing seeks approval in the treatment of patients with advanced NSCLC whose disease has progressed on or after platinum-containing chemotherapy and an FDA-approved therapy for EGFR or ALK genomic tumour aberrations, if present. Under PDUFA, the FDA has 60 days from submission of the sBLA to determine if the application will be accepted for review. The submission is based on data from KEYNOTE-001 in patients with greater than or equal to 50% of tumour cells positive for PD-L1 expression. These data will be presented later today at the American Association for Cancer Research (AACR) Annual Meeting in Philadelphia.

“We are encouraged by the new KEYNOTE-001 data evaluating Keytruda in patients with advanced NSCLC, which will be presented today at AACR Annual Meeting,” said Dr Roger M. Perlmutter, president, Merck Research Laboratories. “We look forward to the FDA’s review of our supplemental application for Keytruda, which is based in part on these data.”

A Premarket Approval Application (PMA) was submitted by Dako North America, Inc., an Agilent Technologies Company, for an immunohistochemistry companion diagnostic test that detects PD-L1 expression, PD-L1 IHC 22C3 PharmDx.