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FDA: Keytruda Approved for Advanced Melanoma

Approved to treat patients with advanced melanoma who are no longer responding to other drugs

FRIDAY, Sept. 5, 2014 (HealthDay News) -- Keytruda (pembrolizumab) has been approved by the U.S. Food and Drug Administration to treat patients with advanced melanoma who are no longer responding to other drugs.

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 approved drug that blocks the cellular pathway PD-1 and is intended for use following treatment with ipilimumab. For melanoma patients whose tumors express the gene mutation BRAF V600, Keytruda is intended for use after treatment with ipilimumab and a BRAF inhibitor.

The drug was evaluated in a clinical trial involving about 600 people with advanced melanoma whose disease progressed despite treatment. The most common side effects included fatigue, cough, nausea, pruritus, and loss of appetite. The agency also warned of possible severe immune reactions involving healthy organs, including the lung, colon, endocrine glands, and liver.

Keytruda is produced by Merck & Co., based in Whitehouse Station, N.J.

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