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Opdivo Approved for Advanced Melanoma

Drug helps harness immune system to attack the cancer

Please note: This article was published more than one year ago. The facts and conclusions presented may have since changed and may no longer be accurate. And "More information" links may no longer work. Questions about personal health should always be referred to a physician or other health care professional.

MONDAY, Dec. 22, 2014 (HealthDay News) -- Opdivo (nivolumab) has been approved by the U.S. Food and Drug Administration to treat advanced melanoma skin cancer that has either spread or can't be treated with surgery, the agency said Monday.

Melanoma, the fifth most common skin cancer in the United States, will strike more than 76,000 Americans this year and more than 9,700 will die from it, the U.S. National Cancer Institute projects.

Opdivo inhibits a protein that prevents the body's immune system from attacking melanoma tumors, the FDA said in a news release.

The drug's safety and effectiveness were evaluated in clinical studies involving 120 people with melanoma that had either spread or couldn't be removed by surgery. Some 32 percent of people who took the drug had their tumors shrink, and this effect lasted for more than six months in about one-third of these people, the FDA said.

Common side effects included rash, itching, cough, respiratory infection and fluid retention. More serious adverse reactions included immune system impairment involving the lung, colon, liver or kidneys, the FDA said.

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

More information

To learn more about this approval, visit the FDA.


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