FDA grants priority review to Keytruda for advanced NSCLC

The FDA accepted for review the supplemental biologics license application of pembrolizumab for advanced non–small cell lung cancer, according to a press release from the drug’s manufacturer.

Further, the FDA granted priority review and breakthrough therapy designation to pembrolizumab (Keytruda, Merck) — a humanized monoclonal antibody that blocks the interaction between programmed cell death-1 (PD-1) and its ligands, PD-L1 and PD-L2 — for advanced NSCLC with a target action date of October 2, 2015.

The FDA will review the use of pembrolizumab in patients with advanced NSCLC whose disease has progressed on or after platinum chemotherapy and an FDA-approved therapy for epidermal growth factor receptor or ALK genomic tumor aberrations, if present.

The FDA based its decision in part on the results of the KEYNOTE-001 study, which included patients who had PD-L1 expression in at least 50% of their tumor cells. Merck filed for approval of pembrolizumab monotherapy at a dose of 2 mg/kg every 3 weeks, the dosage at which it is approved for advanced melanoma.

“Today’s announcement reflects our commitment to accelerate the development of immunotherapeutic approaches to treat lung cancer, one of the most deadly malignancies,” Roger M. Perlmutter, MD, PhD, president of Merck Research Laboratories, said in a press release. “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.”