FDA Accepts Merck’s Lung Cancer sBLA for Keytruda

The US Food and Drug Administration (FDA) has accepted Merck & Co. Inc.’s supplemental biologics license application (sBLA) for Merck's anti-PD-1 therapy, Keytruda (pembrolizumab), for the treatment of patients with advanced non-small cell lung cancer (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.

As previously announced, 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.

Keytruda (pembrolizumab) is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, KEYTRUDA releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. Keytruda is indicated in the United States at a dose of 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Merck is advancing a broad and fast-growing clinical development program for Keytuda with more than 100 clinical trials across more than 30 tumor types and enrolling more than 16,000 patients, both as a monotherapy and in combination with other therapies.

Source: Merck & Co. Inc.

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