FDA Grants Priority Review to Merck's Lung Cancer Drug


The FDA has granted priority review to Merck's pembrolizumab (Keytruda) for the treatment of advanced non-small cell lung cancer (NSCLC).

The FDA has granted priority review to Merck’s pembrolizumab (Keytruda) for the treatment of advanced non-small cell lung cancer (NSCLC) in patients whose disease has progressed on or following platinum-based chemotherapy.

The drug was previously granted Breakthrough Therapy designation from the FDA for this indication, and it is currently approved for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and a BRAF inhibitor in those who are BRAF V600 mutation-positive.

Merck has filed for FDA approval of Keytruda monotherapy in advanced NSCLC at a dose of 2 mg/kg every 3 weeks, which is the currently approved dose for advanced melanoma.

Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, releasing the PD-1 pathway-mediated inhibition of the immune response, including anti-tumor immune response.

The supplemental Biologics License Application (sBLA) submission for Keytruda in NSCLC was partially based on positive data from the KEYNOTE-001 study, which also served as the basis for the drug’s Breakthrough Therapy designation.

“We believe that data submitted to the FDA illustrate the significant potential of Keytruda to treat advanced NSCLC, and we look forward to working with the FDA to bring our anti-PD-1 therapy to patients afflicted with this devastating cancer,” said Merck Research Laboratories president Roger Perlmutter in a press release.

The FDA’s target action date for this sBLA is October 2, 2015.

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