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Merck Says FDA Accepts SBLA For KEYTRUDA

Merck (MRK), known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration has accepted for review the supplemental Biologics License Application or sBLA for Merck's anti-PD-1 therapy, KEYTRUDA (pembrolizumab), for the treatment of patients with advanced non-small cell lung cancer or 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.

The FDA granted Priority Review with a PDUFA, or target action, date of October 2, 2015; the sBLA will be reviewed under the FDA's Accelerated Approval program.

The sBLA submission was based in part on data from KEYNOTE-001 - including patients with greater than or equal to 50 percent of tumor cells positive for PD-L1 expression - which were presented at the 2015 American Association for Cancer Research (AACR) Annual Meeting (link).

These data also served as the basis for the FDA Breakthrough Therapy designation for KEYTRUDA in advanced NSCLC. Merck has filed for approval of KEYTRUDA monotherapy at a dose of 2 mg/kg every three weeks, which is the currently approved dose for advanced melanoma.

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