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FDA grants priority review to GSK drug
September 17, 2013
By: TOM BRANNA
Editor
A treatment for melanoma, the deadliest form of skin cancer, may be at hand. GlaxoSmithKline plc today announced that the US Food and Drug Administration (FDA) has granted Priority Review designation to its supplemental New Drug Applications (sNDAs) for combined use of Tafinlar (dabrafenib) and Mekinist (trametinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 E or K mutation. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) tar...
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