GSK cancer drug combination gets U.S. priority review
LONDON, Sept 16
LONDON, Sept 16 (Reuters) - A combination treatment from GlaxoSmithkline for melanoma, the deadliest form of skin cancer, has won priority review from U.S. regulators.
GSK said on Monday the Food and Drug Administration had prioritised a review of a combination of dabrafenib and trametinib to treat melanoma that cannot be removed by surgery or which has spread to other organs.
The agency set a target date of Jan. 8, 2014 for the review of the trametinib supplement and Jan. 9 for the dabrafenib supplement, GSK said in a statement.
The applications are based on data from a randomised study comparing combination therapy with dabrafenib and trametinib to dabrafenib monotherapy in adult patients with certain types of cancer.
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