Drug news
FDA priority review for Tafinlar+Mekinist for Melanoma
The FDA has granted Priority Review designation to a supplemental New Drug Applications (sNDAs) from GSK for combined use of Tafinlar (dabrafenib) and Mekinist (trametinib) for the treatment of adult patients with unresectable or Metastatic Mmelanoma with a BRAF V600 E or K mutation. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of 8 January 2014 for the Mekinist (trametinib) supplement and 9 January 2014 for the Tafinlar (dabrafenib) supplement.
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