Dako, an Agilent Technologies Company, Announces FDA Approval of New Test for Lung Cancer Patients

Dako, an Agilent Technologies company and a worldwide provider of cancer diagnostics, today announced the U.S. Food and Drug Administration has approved a new test that can identify PD-L1 expression levels on the surface of non-small cell lung cancer tumor cells and provide information on the survival benefit with OPDIVO® (nivolumab) for patients with non-squamous NSCLC. Dako developed the diagnostic, known as PD-L1 IHC 28-8 pharmDx, through a collaboration with Bristol-Myers Squibb, the maker of OPDIVO®, an immuno-oncology therapy approved by the FDA for the treatment of all patients with previously treated NSCLC. The diagnostic was used to assess PD-L1 expression in the Phase 3 CheckMate 057 trial, in which OPDIVO® demonstrated superior overall survival in patients with previously treated metastatic non-squamous NSCLC compared to chemotherapy. The FDA today expanded the indication for OPDIVO® to include previously treated non-squamous NSCLC in addition to the squamous NSCLC indication. Lung cancer is the leading cause of cancer-related deaths worldwide. Historically, the one-year overall survival in the second-line treatment of NSCLC has been about 26 percent. "Immuno-oncology is an important area within cancer treatment, and we are excited about Agilent's involvement in these advancements and the potential PD-L1 IHC 28-8 pharmDx has in helping to provide information to oncologists considering OPDIVO for patients with non-squamous non-small cell lung cancer," said Jacob Thaysen, president of Agilent's Diagnostics and Genomics Group. "We are proud to announce the recent FDA approval of OPDIVO based upon overall survival in an expanded indication for all appropriate patients with previously treated metastatic non-small cell lung cancer," added Michael Giordano, senior vice president and head of Development, Oncology, at Bristol-Myers Squibb. "Our collaboration with Dako underscores our leadership in cancer innovation and our commitment to advancing research evaluating the potential role of PD-L1 in multiple tumor types." PD-L1 IHC 28-8 pharmDx is the first and only diagnostic assay approved to assess the survival benefit associated with OPDIVO®. PD-L1 testing is not required for the use of OPDIVO®, but it may provide additional information for physicians and inform patient dialogue. Dako is a worldwide leader in partnering with pharmaceutical companies to develop immunohistochemical-based diagnostics for cancer therapy.