GSK withdraws MAA for melanoma combo

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) withdrew an MAA for Tafinlar dabrafenib in combination with Mekinist trametinib to treat unresectable or metastatic melanoma in adults with a BRAF V600 mutation. According to the pharma, EMA's CHMP could not "conclude on a positive benefit-risk balance of the combination" based on data provided by GSK. The pharma said it plans to resubmit the MAA based on data from the ongoing Phase III COMBI-d and COMBI-v trials.

The European Commission approved Tafinlar as monotherapy last year; an MAA for Mekinist as monotherapy is still under review. Tafinlar is an oral BRAF protein kinase inhibitor, and Mekinist is a small molecule inhibitor of MAP kinase kinase 1 ( MAP2K1; MEK1) and MEK2. ...