Home Alzheimer’s Disease FDA Approves Combination of Nivolumab Plus Ipilimumab for mNSCLC

FDA Approves Combination of Nivolumab Plus Ipilimumab for mNSCLC

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…

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