FDA gives thumbs up to Agilentís CDx
SANTA CLARA, Calif.—A new assay is joining the ranks of approved companion diagnostics, as Agilent Technologies Inc.’s PD-L1 IHC 28-8 pharmDx got the nod from the U.S. Food and Drug Administration for expanded use in non-small cell lung cancer (NSCLC). The assay helps to determine which patients with metastatic NSCLC might benefit from treatment with a combination regimen of Opdivo (nivolumab) and Yervoy (ipilimumab). Agilent developed this companion diagnostic in 2016 under a collaboration with Bristol-Myers Squibb, and it has been approved as a complementary diagnostic for other cancer types as well.
“The expanded use of PD-L1 IHC 28-8 pharmDx will give physicians in the USA critical information to inform first-line treatment decisions for patients with metastatic non-small cell lung cancer,” said Sam Raha, president of Agilent’s Diagnostics and Genomics Group.