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FDA NewsLung CancerNewsworthy

FDA Approved Opdivo for Metastatic Small-Cell Lung Cancer

October 2018 Vol 4 No 5

In August 2018, the FDA approved the immunotherapy Opdivo (nivolumab; from Bristol-Myers Squibb) for the treatment of patients with metastatic (spreading) small-cell lung cancer that progressed after platinum-based chemotherapy and at least 1 other therapy.

Opdivo was previously approved by the FDA for patients with non–small-cell lung cancer, the most common type of lung cancer. This new approval makes this immunotherapy also available for patients with small-cell lung cancer, which has fewer treatment options.

This approval was based on results from a clinical trial of 109 patients with or without PD-1 expression who had metastatic small-cell lung cancer that progressed after chemotherapy and at least 1 other therapy.

Overall, in 13 patients with small-cell lung cancer, the cancer responded to treatment with Opdivo, and the responses lasted between 6 months to more than 18 months. This new approval for Opdivo now offers patients with small-cell lung cancer access to immunotherapy, an important addition to the treatment options available for patients with this type of lung cancer.

The side effects with Opdivo in this study were similar to those seen in other studies, and 10% of patients discontinued treatment because of side effects.

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Last modified: October 27, 2018

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