LONDON, Jan 9 (Reuters) - A combination treatment fromGlaxoSmithKline for melanoma, the deadliest form of skincancer, has won accelerated approval from U.S. regulators.
The green light for the combined use of Tafinlar, also knownas dabrafenib, and Mekinist, or trametinib, from the Food andDrug Administration (FDA) is the first of its kind for a form ofthe disease with a specific genetic profile.
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.
The FDA approval, which was announced late on Wednesday,covers the treatment of melanoma that cannot be removed bysurgery or which has spread to other organs.
Melanoma is diagnosed in nearly 160,000 people worldwideeach year. It can spread quickly to internal organs and averagesurvival is six to nine months.