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U.S. FDA approves two-drug combination for advanced melanoma

English.news.cn   2014-01-11 00:59:20            

WASHINGTON, Jan. 10 (Xinhua) -- The U.S. Food and Drug Administration (FDA) said Friday it approved a two-drug combination for the treatment of advanced melanoma, the deadliest form of skin cancer.

The safety and effectiveness of Mekinist (trametinib) in combination with Tafinlar (dabrafenib) were demonstrated in a clinical trial of 162 participants with melanoma that is late- stage or cannot be removed by surgery, the FDA said.

They are specifically indicated as a combination therapy for melanoma patients with gene mutations called BRAF V600E and V600K, it said.

Both drugs were approved last year for single-agent use.

"Mekinist and Tafinlar are the first drugs approved for combination treatment of melanoma," said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, in a statement.

"Their development for combination use is based on the strong understanding of the biological pathways of the disease," Pazdur said.

According to the FDA, melanoma is the most aggressive type of skin cancer and the leading cause of death from skin disease. The U.S. National Cancer Institute estimated that 76,690 Americans would be diagnosed with melanoma and 9,480 would die from the disease in 2013.

Editor: yan
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