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FDA Approves Nivolumab for Some Melanomas and Lung Cancers

November 10, 2015, by NCI Staff

Image of a group of cytotoxic T cells (green and red) surrounding a cancer cell (blue, center).

Credit: National Institutes of Health / CC BY 2.0

The Food and Drug Administration (FDA) has expanded the approved uses of the immunotherapy agent nivolumab (Opdivo®).

On September 30, the FDA granted accelerated approval to nivolumab in combination with the antibody ipilimumab (Yervoy®) to treat patients with unresectable or metastatic melanoma that does not have a BRAF V600 mutation. And on October 9, the FDA approved nivolumab for the treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC) whose disease has progressed despite treatment with platinum-based chemotherapy.

The melanoma approval was based on the results of an international randomized clinical trial in previously untreated patients. The double-blind trial randomly assigned 95 patients to receive nivolumab plus ipilimumab and 47 patients to receive ipilimumab plus placebo.

Among 109 patients with BRAF V600 wild-type melanoma, 60 percent of patients who received the combination of nivolumab and ipilimumab experienced some reduction in tumor size (objective response), compared with 11 percent of those who received ipilimumab and placebo. Of the 43 patients who experienced an objective response on the nivolumab-plus-ipilimumab combination, 34 patients (79 percent) had ongoing responses of at least 6 months to more than 9 months at the time of the final analysis. Estimated progression-free survival for patients receiving nivolumab and ipilimumab was 8.9 months, compared with 4.7 months among those receiving ipilimumab and placebo.

Serious adverse reactions occurred in 62 percent of all study patients who received the combination therapy and in 39 percent of those who received ipilimumab and placebo. Patients receiving nivolumab and ipilimumab were more likely to experience grade 3 or 4 adverse events, and they were more likely to delay or discontinue treatment.

The approval for nonsquamous NSCLC was based on an improvement in overall survival in an international randomized phase III clinical trial. In the trial, 582 people with metastatic nonsquamous NSCLC whose disease progressed during or after platinum-based chemotherapy were randomly assigned to treatment with nivolumab or the chemotherapy drug docetaxel.

At the time of analysis, median overall survival was 12.2 months for patients receiving nivolumab and 9.4 months for those receiving docetaxel. The overall response rate was 19 percent for patients who received nivolumab, compared with 12 percent for patients who received docetaxel. The median durations of response were 17 months and 6 months, respectively.  

This approval expands the indication for nivolumab to include nonsquamous types of NSCLC. The FDA previously approved nivolumab for patients with metastatic squamous NSCLC whose disease progressed during or after platinum-based chemotherapy.

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