Opdivo Approval Expanded to Include Lung Cancer

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U.S. Food and Drug Administration approval of Opdivo (nivolumab) has been expanded to include advanced non-small cell lung cancer (NSCLC), the agency said Wednesday in a news release.

Lung cancer is the leading cause of cancer death in the United States, having been diagnosed more than 224,000 times and causing more than 159,000 deaths in 2014, the FDA said. NSCLC is the most common type, affecting seven of eight people with lung cancer.

Opdivo inhibits a protein that prevents the immune system from attacking cancer cells, the agency said. The drug is sanctioned for people who have been treated with platinum-based chemotherapy.

Opdivo was clinically compared to another anti-cancer drug, docetaxel, in a study involving more than 270 people with NSCLC. People who received Opdivo lived an average of 3.2 months longer than people given docetaxel, the FDA said.

The most common side effects of Opdivo are fatigue, shortness of breath, muscle and bone pain, loss of appetite, cough, nausea and constipation. More severe adverse effects included immune reactions involving healthy organs, including the lungs, colon, liver, kidneys and hormone-producing glands.

Opdivo was approved previously to treat advanced melanoma among people who don’t respond to other medicines.

The drug is marketed by Bristol-Myers Squibb, based in Princeton, N.J.

More information

Visit the FDA to learn more.

Source: HealthDay

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