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Melanoma, accounting for about 5 percent of new cancers in the United States, is expected to be diagnosed in more than 76,000 Americans and about 9,710 are projected to die from it this year, the FDA said in a news release.
Keytruda is the first in a new class of drugs designed to help the body's immune system attack melanoma cells. It's intended to treat people who are no longer responding to other drugs, the FDA said.
The drug was evaluated in a clinical trials involving about 600 people with advanced melanoma whose disease progressed despite treatment. The most common side effects included fatigue, cough, nausea, itchy skin and loss of appetite.
The agency also warned of possible severe immune reactions involving healthy organs including the lung, colon, hormone-producing glands and liver.
Keytruda is produced by Merck & Co., based in Whitehouse Station, N.J.
-- Scott Roberts
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