Pierre Fabre combo follows up US approval with EC nod

Privately-held French drugmaker Pierre Fabre has announced that the European Commission (EC) has approved the combination of Braftovi (encorafenib) and Mektovi (binimetinib) for unresectable or metastatic melanoma with a BRAF mutation, as detected by a validated test.

The EC decision comes three months after US approval was granted to Pierre Fabre’s partner Array BioPharma (Nasdaq: ARRY) to market the combination in this indication and was again based on positive data showing that the two drugs almost double survival in BRAF-positive melanoma compared to the Roche (ROG:SIX) therapy Zelboraf (vemurafenib).

Braftovi is an oral small-molecule BRAF kinase inhibitor and Mektovi is an oral small-molecule MEK inhibitor that targets key enzymes in the MAPK signalling pathway.