FDA accepts Merck's sBLA for Keytruda as first-line NSCLC treatment

The US Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application (sBLA) from pharma giant Merck & Co (NYSE: MRK) for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1, with a PDUFA, or target action, date of December 24, 2016.

Additionally, the FDA granted Breakthrough Therapy designation for this indication. Merck has also submitted a Marketing Authorization Application to the European Medicines Agency for this indication, the company said.

Last fall, Keytruda was approved as a second-line treatment in patients with non-small-cell lung cancer whose tumors contain a certain level of a protein known as PD-L1, and whose disease continued to worsen after the patient received chemotherapy or other drugs. Keytruda is Merck's fastest growing drugs, generating over $314 million in sales in the second quarter of 2016. GlobalData is forecasting multi-blockbuster sales of around $7 billion for Keytruda by 2024,