The Food and Drug Administration has expanded approval of the PD-1 inhibitor nivolumab to include treatment of patients who have metastatic squamous non–small cell lung cancer and progress following platinum-based chemotherapy.
In December, the FDA approved nivolumab to treat patients who have metastatic melanoma and no longer respond to other drugs.
Nivolumab for squamous non–small cell lung cancer (NSCLC) was reviewed under the FDA’s priority review program, and is being approved more than 3 months ahead of schedule, the FDA said in the March 4 announcement .
Efficacy was established in a trial of 272 patients with metastatic squamous NSCLC; median overall survival was increased by 3.2 months in 135 patients who received nivolumab, compared with 137 who received docetaxel.
The safety and efficacy of nivolumab to treat squamous NSCLC was also supported by a single-arm trial of 117 participants who had progressed after receiving a platinum-based therapy and at least one additional systemic regimen. The objective response rate was 15%, of whom 59% had response durations of 6 months or longer, according the the FDA statement.
The most common side effects of nivolumab are fatigue, shortness of breath, musculoskeletal pain, decreased appetite, cough, nausea, and constipation. The most serious side effects are severe immune-mediated side effects involving healthy organs, including the lung, colon, liver, kidneys, and hormone-producing glands, the FDA said.
The drug is marketed as Opdivo by Bristol-Myers Squibb.
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