Merck & Co. Gets Priority Review for New Use of Lung Cancer Drug
Merck & Co. has received priority review from the US Food and Drug Administration for a supplemental biologics license application for Keytruda (pembrolizumab), the company’s anti-programmed cell death protein-1 therapy, for first-line treatment of advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1. The target action date for the priority review is in December 2016. The FDA also granted breakthrough therapy designation for this indication. Merck has also submitted a marketing authorization application to the European Medicines Agency for this indication.
Merck previously announced that Keytruda 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.
Keytruda was approved by the FDA in September 2014 for treating patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. To date in the US, it is also indicated for patients with metastatic NSCLC whose tumors express PD-L1 and who have disease progression on or after platinum-containing chemotherapy; and for patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy.
Source: Merck & Co.