FDA Approves Merck’s Keytruda for Lung Cancer

The FDA Oct. 2 granted accelerated approval to Keytruda (pembrolizumab) 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, the Food and Drug Administration said. Keytruda is marketed by Whitehouse Station, N.J.-based Merck & Co., and the diagnostic test is marketed by Dako North America Inc. in Carpinteria, Calif.

“Our growing understanding ...