LONDON, Sept 16 A combination treatment from
GlaxoSmithkline for melanoma, the deadliest form of skin
cancer, has won priority review from U.S. regulators.
The move means the Food and Drug Administration will now
decide whether to approve the dual use of Tafinlar, also known
as dabrafenib, and Mekinist, or trametinib, by early January.
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 potential.
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 tumours 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
GSK said on Monday that the FDA had set a target date of
Jan. 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 treat
melanoma that cannot be removed by surgery or which has spread
to other organs. The applications are based on data from a
randomised study comparing combination therapy to Tafinlar given
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.