The FDA approved the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
In addition, the FDA also approved the PD-L1 IHC 28-8 pharmDx as a companion diagnostic device for selecting patients with NSCLC for treatment with the combination of nivolumab plus ipilimumab.
The FDA recommended doses for metastatic NSCLC treatment are 3 mg/kg of nivolumab every 2 weeks and 1 mg/kg of ipilimumab every 6 weeks until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression.
Efficacy was investigated in the CHECKMATE-227 trial, a randomized, open-label, multi-part trial…
