melanoma drug combination wins accelerated U.S. approval
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[January 09, 2014]
— A combination treatment from GlaxoSmithKline for
melanoma, the deadliest form of skin cancer, has won accelerated
approval from U.S. regulators.
The green light for the combined use of Tafinlar,
also known as dabrafenib, and Mekinist, or trametinib, from the Food
and Drug Administration (FDA) is the first of its kind for a form of
the disease with a specific genetic profile.
Both drugs are already approved for separate use but GSK believes
they will have a longer-lasting effect if given together. Industry
analysts also see a combination offering the greatest commercial
Tafinlar, which is similar to Roche's rival medicine Zelboraf, is
designed to work in patients with a mutation of a gene known as BRAF.
So-called BRAF inhibitors have been remarkably effective in
shrinking melanoma tumors but most patients eventually develop
resistance to the drugs.
By combining Tafinlar with Mekinist, which works in a different way,
the hope is that the cancer will be held at bay for longer.
The FDA approval, which was announced late on Wednesday, covers the
treatment of melanoma that cannot be removed by surgery or which has
spread to other organs.
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Melanoma is diagnosed in nearly 160,000 people worldwide each
year. It can spread quickly to internal organs and average survival
is six to nine months.
(Reporting by Ben Hirschler; editing by
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