FDA approves expanded use of Keytruda, for advanced NSCLC

The US Food and Drug Administration on Friday granted accelerated approval for pharma giant Merck & Co’s (NYSE: MRK) Keytruda (pembrolizumab) in a new indication. The firm’s shares rose 1.56% to $50.14 on the news.

The new approval is for the treatment of patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express a protein called PD-L1. Keytruda is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, the first test designed to detect PD-L1 expression in non-small cell lung tumors.

Under FDA’s accelerated approval regulations, this indication for Keytruda is approved based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.