Horizon scanning: EU regulatory filing submitted for trametinib for metastatic melanoma

Source: BioSpace Area: News According to a BioSpace report, GlaxoSmithKline (GSK) has submitted a regulatory application to the European Medicines Agency (EMA) for trametinib as a monotherapy for BRAF V600 mutation-positive metastatic melanoma. The application is supported by data from a phase III study which evaluated the use of trametinib versus dacarbazine or paclitaxel monotherapy in BRAF V600 mutation positive metastatic melanoma patients (see NELM abstract below).   GSK is also looking to get trametinib in combination with dabrafenib, approved for use in adults with BRAF V600 mutation-positive metastatic melanoma.   Both applications for trametinib as monotherapy and combination therapy have been granted accelerated assessment by EMA's Committee for Medicinal Products for Human Use (CHMP). A final decision by the European Commission (EC) is expected by mid-Jul 2013.
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news