FDA Grants Priority Review to Pembrolizumab Supplemental Biologics License Application for First-Line Treatment of Advanced NSCLC

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The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda), an anti–PD-1 (programmed cell death protein 1) therapy, for the first-line treatment of patients with advanced non–small cell lung cancer (NSCLC) whose tumors express PD-L1 (programmed death-ligand 1). The target action date is December 24, 2016. Additionally, the FDA granted Breakthrough Therapy designation for this indication.

The submissions were based on data from the pivotal phase III KEYNOTE-024 study, which showed that pembrolizumab monotherapy resulted in superior progression-free survival as well as overall survival compared with standard chemotherapy in patients with advanced NSCLC whose tumors expressed high levels of PD-L1 (tumor proportion score of 50% or more).1 Based on the results, the trial was stopped early to give patients still on chemotherapy the opportunity to receive pembrolizumab. Merck filed for approval of pembrolizumab in the first-line setting at a dose of 200 mg every 3 weeks, the dose studied in KEYNOTE-024.

“Chemotherapy has been the foundation of first-line treatment for non–small cell lung cancer for decades, so the significant improvement in survival in patients with high PD-L1 expression seen with pembrolizumab compared to chemotherapy is welcome news,” said Roger M. Perlmutter, MD, PhD, President, Merck Research Laboratories. “We appreciate the opportunity to work with regulatory authorities to make pembrolizumab a first-line treatment option in non–small cell lung cancer.”

The FDA’s Breakthrough Therapy designation is intended to expedite the availability of promising new therapies that are planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates substantial improvement over existing therapies on one or more clinically significant endpoints. Merck previously announced that pembrolizumab was granted breakthrough status for specific patients with advanced melanoma; metastatic NSCLC in previously treated patients; microsatellite instability high metastatic colorectal cancer; and relapsed or refractory classical Hodgkin Lymphoma.

About Pembrolizumab

Pembrolizumab is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Pembrolizumab blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T-lymphocytes which may affect both tumor cells and healthy cells.

Pembrolizumab is administered as an intravenous infusion over 30 minutes every 3 weeks for the approved indications. Pembrolizumab for injection is supplied in a 100-mg single-use vial. ■


1. Study of pembrolizumab (MK-3475) compared to platinum-based chemotherapies in participants with metastatic non-small cell lung cancer (MK-3475-024/KEYNOTE-024). Identifier: NCT02142738.