For patients with metastatic squamous non-small-cell lung cancer (SQ NSCLC), nivolumab has been granted U.S. Food and Drug Administration approval. The benefit-risk summary was reviewed in a report published in JAMA Oncology.

Dickran Kazandjian, M.D., from the FDA in Silver Spring, Maryland, and colleagues provided a benefit-risk summary based on a planned interim analysis of a trial in second-line metastatic SQ NSCLC involving 272 patients. Participants were randomized to receive nivolumab (135 patients) or docetaxel (137 patients).

The researchers found that median overall survival was 9.2 and six months for patients randomized to nivolumab and docetaxel, respectively (hazard ratio, 0.59).

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In a single-arm trial involving 117 patients with previously treated metastatic SQ NSCLC, they assessed the safety of nivolumab; the safety profile was found to be consistent with that in melanoma.

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There were serious immune-mediated adverse events, which were rare and managed with corticosteroids and dose interruption.

“The FDA granted nivolumab traditional approval on March 4, 2015, for treatment of metastatic SQ NSCLC with progression during or after platinum-based chemotherapy,” the authors write. “The approval provides an important treatment option for these patients, affecting routine care and clinical trials.”


  1. Kazandjian D, Khozin S, Blumenthal G, et al. Benefit-Risk Summary of Nivolumab for Patients With Metastatic Squamous Cell Lung Cancer After Platinum-Based Chemotherapy: A Report From the US Food and Drug Administration. JAMA Oncology. [published online ahead of print October 15, 2015]. doi:10.1001/jamaoncol.2015.3934.