Merck Announces Submission of Supplemental Biologics License Application (sBLA) to U.S. FDA for KEYTRUDA® (pembrolizumab) in Advanced Non-Small Cell Lung Cancer

April 19, 2015 12:15 PM

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Merck (MRK), known as MSD outside the United States and Canada, today announced that the company has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration (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 tumor 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 percent of tumor 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 non-small cell lung cancer, 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 supplement...

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