GSK gets EU fast track for MEK & BRAF/MEK in melanoma
This article was originally published in Scrip
Executive Summary
GlaxoSmithKline has submitted a marketing authorization application to the European Medicines Agency ( EMA) for the in-licensed novel MEK inhibitor trametinib as monotherapy and in combination with its BRAF inhibitor dabrafenib to treat metastatic melanoma. The agency's Committee for Medicinal Products for Human Use ( CHMP) has granted the company's request for accelerated assessment, meaning that it will have a maximum review time of 150 days, versus the standard timeline of up to 210 days.