FDA Approves Merck’s Keytruda (Ab to PD-1) for Treatment of Advanced Non-Small-Cell Lung Cancer (85% of All Lung Cancer); Companion Test to ID Patients Most Likely to Benefit Also Approved

Pembrolizumab (trade name Keytruda), a drug that has already been proven to extend the lives of people with advanced melanoma, was approved on October 2, 2015 by the U.S. Food and Drug Administration (FDA) to treat advanced non-small-cell lung cancer (NSCLC) in patients whose tumors express the protein PD-L1 (programmed cell death ligand 1). Keytruda is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, which is the first test designed to detect PD-L1 expression in NSCLC. Keytruda is marketed by Merck & Co., based in Whitehouse Station, New Jersey, and the PD-L1 IHC 22C3 pharmDx diagnostic test is marketed by Dako North America Inc. in Carpinteria, California. Richard Pazdur, M.D., Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research said that the “approval of Keytruda gives physicians the ability to target specific patients who may be most likely to benefit from this drug.” The clinical trial study of Keytruda in advanced NSCLC represents the largest published research to date using immunotherapy to treat lung cancer, and the trial was conducted at UCLA and 29 other sites in the U.S., Europe, and Australia. “The approval of this drug and a test to identify patients most likely to benefit has the potential to transform the way that lung cancer is treated,” said Dr. Edward Garon, the study’s principal investigator and a researcher at UCLA’s Jonsson Comprehensive Cancer Center. “The quality and duration of disease response that was seen in the trial had previously been extremely rare in lung cancer.
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