Agilent's Dako Announces FDA Approval of New Test for Lung Cancer Patients, PD-L1 IHC 28-8 pharmD

Dako, an Agilent Technologies

company and a worldwide provider of cancer diagnostics, announced Oct. 9 that 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 on Oct. 9 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