FDA Approves BMS' Opdivo, Yervoy With CDx in First-Line PD-L1-Expressing Lung Cancer

NEW YORK – Bristol Myers Squibb said on Friday that the US Food and Drug Administration approved the combination of PD-1 inhibitor nivolumab (Opdivo) and CTLA-4 inhibitor ipilimumab (Yervoy) as a first-line treatment for PD-L1 expressing, metastatic non-small cell lung cancer with no EGFR or ALK mutations, as determined by an FDA-approved test.

The FDA also approved the PD-L1 IHC 28-8 pharmDx by Agilent Technologies as a companion diagnostic device for selecting NSCLC patients for treatment with the nivolumab and ipilimumab combination.