LONDON (Reuters) - A combination treatment from GlaxoSmithkline (LSE:GSK) 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 January 8, 2014 for the review of the trametinib supplement and January 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.
(Reporting by Paul Sandle; Editing by Ben Hirschler)
- Disease & Medical Conditions
- Food and Drug Administration
- skin cancer