UPDATE 1-FDA approves two Glaxo melanoma drugs

Wed May 29, 2013 3:29pm EDT

May 29 (Reuters) - U.S. health regulators on Wednesday approved a pair of GlaxoSmithKline Plc drugs to treat advanced melanoma - the deadliest form of skin cancer - in patients with specific genetic mutations. It also approved a diagnostic test to detect the mutations.

The Food and Drug Administration said it approved the drugs, Tafinlar and Mekinist, to be used as single agents and not in combination after the medicines delayed tumor growth in separate clinical trials.

After decades with virtually no progress in the fight against advanced melanoma and little to offer patients facing a virtual death sentence, Tafinlar and Mekinist mark the third and fourth new drugs approved by the FDA for metastatic melanoma in the past two years.

Tafinlar, known chemically as dabrafenib, belongs to a class of cancer drugs called as BRAF inhibitors. Mekinist, known chemically as trametinib, inhibits a protein associated with cancerous tumors known as MEK.

Tafinlar was approved to treat patients with melanoma whose tumors express the BRAF V600E gene mutation. Mekinist was approved to treat patients whose tumors express either the BRAF V600E or V600K gene mutations. About half of skin melanomas have a BRAF mutation.

The FDA also approved the THxID BRAF test, made by France's bioMérieux, which will be used to determine if a patient's melanoma cells have the V600E or V600K mutation in the BRAF gene.

Analysts at Cowen and Co forecast sales reaching about $350 million for each drug in 2016.

An estimated 76,690 Americans will be diagnosed with melanoma and 9,480 will die from the disease in 2013, according to the National Cancer Institute.

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