FDA Accepts sBLA for Merck’s Cancer Drug Keytruda

The US Food and Drug Administration (FDA) has accepted for review a supplemental biologics license application (sBLA) for Merck & Co. Inc.’s Keytruda (pembrolizumab), an anti-PD-1 therapy. Merck is seeking approval for Keytruda, at the currently approved dose of 2 mg/kg every three weeks, for the first-line treatment of unresectable or metastatic melanoma patients. The FDA granted priority review with a target action, date of December 19, 2015. Additionally, the FDA has extended the action date for a separate sBLA for Keytruda for the treatment of patients with ipilimumab-refractory advanced melanoma. The new action date is now December 24, 2015.

Keytruda is currently 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.

Keytruda 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. Merck is advancing a broad clinical development program for Keytruda 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.

Keytruda is positioned as a potential blockbuster for Merck with 2019 projected sales of $3.466 billion, according to a recent Thomson Reuters analysis.

Source: Merck & Co. Inc.

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