GSK files trametinib at the FDA for Metastatic Melanoma - 07-Aug-2012

GSK has filed trametinib, a drug developed by Japan Tobacco , at the FDA to treat unresectable Metastatic Melanoma and is planning a EU filing. The molecule targets patients with BRAF V600 mutation positive forms of Metastatic Melanoma. The V600 mutation applies to some 60% of Melanoma patients. A companion diagnostic has already been filed by BioMerieux. The application is supported by the METRIC study results where the drug showed a progression free survival of 4.8 months versus 1.5 months for dacarbazine chemotherapy and a 55% risk reduction in disease progression or death in the trametinib group.There was also a significant overall surival benefit in the trametanib arm.