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LONDON, Sept 16 (Reuters) - A combination treatment fromGlaxoSmithkline for melanoma, the deadliest form of skincancer, has won priority review from U.S. regulators.
The move means the Food and Drug Administration will nowdecide whether to approve the dual use of Tafinlar, also knownas dabrafenib, and Mekinist, or trametinib, by early January.
Both drugs are already approved for separate use but GSKbelieves they will have a longer-lasting effect if giventogether. Industry analysts also see a combination offering thegreatest commercial potential.
Tafinlar, which is similar to Roche's rivalmedicine Zelboraf, is designed to work in patients with amutation of a gene known as BRAF. So-called BRAF inhibitors havebeen remarkably effective in shrinking melanoma tumours but mostpatients eventually develop resistance to the drugs.
By combining Tafinlar with Mekinist, which works in adifferent way, the hope is that the cancer will be held at bayfor longer.
GSK said on Monday that the FDA had set a target date ofJan. 8, 2014 for the review of the Mekinist supplement and Jan.9 for the Tafinlar supplement.
If approved, the drug combination will be used to treatmelanoma that cannot be removed by surgery or which has spreadto other organs. The applications are based on data from arandomised study comparing combination therapy to Tafinlar givenalone.
Melanoma is diagnosed in nearly 160,000 people worldwideeach year. It can spread quickly to internal organs and averagesurvival is six to nine months.
