Dako, an Agilent Technologies Company, Announces FDA Approval of New Companion Diagnostic for Lung Cancer

Dako, an Agilent Technologies company and a worldwide provider of cancer diagnostics, today announced the U.S. Food and Drug Administration (FDA) approval of a new companion diagnostic assay that can reveal whether a patient with advanced non-small cell lung cancer (NSCLC) is likely to respond to a new form of treatment. The approval of PD-L1 IHC 22C3 pharmDx strengthens Dako's portfolio of companion diagnostics and the company's leadership position in developing and commercializing companion diagnostic products. Dako developed PD-L1 IHC 22C3 pharmDx in partnership with Merck & Co., Inc. (known as MSD outside the U.S. and Canada), maker of the anti-PD-1 therapy KEYTRUDA® (pembrolizumab). KEYTRUDA is approved by the FDA to treat patients with metastatic NSCLC whose tumors express PD-L1 as determined by the companion diagnostic assay and who have disease progression on or after platinum-containing chemotherapy. KEYTRUDA is an immunotherapy that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby helping the immune system do what it is meant to do: help detect and fight cancer cells. KEYTRUDA can also cause the immune system to attack normal organs and tissues. The FDA today approved PD-L1 IHC 22C3 pharmDx for use in the United States. Dako hopes to gain regulatory approval for the new diagnostic in Canada, Europe and other jurisdictions next year. Lung cancer is the leading cause of cancer-related death worldwide, and NSCLC accounts for 80 percent of all lung cancers. PD-L1 IHC 22C3 pharmDx is the first and only companion diagnostic assay that has been validated and approved to identify NSCLC patients eligible for KEYTRUDA. "Because individuals often respond differently to the same treatment, scientists have been putting more emphasis on personalized medicine, which is where PD-L1 IHC 22C3 pharmDx comes into play," said Jacob Thaysen, president of Agilent's Diagnostics and Genomics Group. "This is a new era in immunoncology, and we are particularly excited about Agilent's involvement in advancements in cancer treatment and the potential PD-L1 IHC 22C3 pharmDx has in helping to identify patients with non-small cell lung cancer who are most likely to benefit from treatment with KEYTRUDA." "The approval of the first PD-L1 diagnostic has the potential to provide information that will help guide treatment decisions for many patients," said Dr. Roger Dansey, senior vice president, Merck Research Laboratories. "PD-L1 is an important new biomarker, and we look forward to working with Dako to make PD-L1 testing a routine part of the diagnosis and treatment of non-small cell lung cancer."