September 7, 2016
Merck has announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab) for Priority Review. KEYTRUDA® is Merck’s anti-PD-1 therapy that is used as the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC). In addition, the FDA granted Breakthrough Therapy Designation for this indication. Merck has also submitted a Marketing Authorization Application to the European Medicines Agency for KEYTRUDA®.
The submissions were based on data from the pivotal phase 3 KEYNOTE-024 study. It showed that KEYTRUDA monotherapy resulted in superior progression-free survival (PFS) as well as overall survival (OS) compared with standard chemotherapy in patients with advanced NSCLC whose tumors expressed high levels of PD-L1 (tumor proportion score of 50 percent or more). Based on the results, the trial was stopped early to give patients still on chemotherapy the opportunity to receive KEYTRUDA.
Dr. Roger M. Perlmutter, president, Merck Research Laboratories, said: “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 KEYTRUDA compared to chemotherapy is welcome news. We appreciate the opportunity to work with regulatory authorities to make KEYTRUDA a first-line treatment option in non-small cell lung cancer.”FDA Accepts Supplemental Biologics License Application for Merck’s KEYTRUDA® (pembrolizumab) for First-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancerlast edit: 2016-09-19T16:47:15+00:00da