GlaxoSmithKline withdraws MAA to EMA for use of Mekinist and Tafinlar in Europe

theflyonthewall.com

GlaxoSmithKline announced that it has withdrawn its Marketing Authorisation Application to the European Medicines Agency for the use of Mekinist in combination with the previously approved BRAF inhibitor Tafinlar for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. The application for the use of Mekinist as a single agent in the same patient population, submitted simultaneously with the MAA for the combination, is still undergoing review by the EMA. The Committee for Medicinal Products for Human Use of the EMA has indicated that the data provided to date by GSK did not allow the Committee to conclude on a positive benefit-risk balance of the combination. GSK intends to re-submit the MAA for the combined use of Tafinlar and Mekinist when additional data from the ongoing Phase III programme become available.

View Comments (0)