Surprise setback: GSK forced to pull EU filing for melanoma combo
This article was originally published in Scrip
Executive Summary
GlaxoSmithKline has withdrawn its marketing authorization application (MAA) in Europe for Mekinist (trametinib) in combination with Tafinlar (dabrafenib) for the treatment of melanoma after the EMA's Committee for Medicinal Products for Human Use (CHMP) demanded more clinical data.