EU Gives Go-Ahead for Metastatic Melanoma Combo Therapy

The EU approved Pierre Fabre’s Braftovi and Mektovi combination therapy for treating adults with unresectable or metastatic melanoma with a BRAFV600 mutation.

The approval was based on data from a Phase III trial, showing 14.9 months of median progression-free survival using the combination, compared to 7.3 months using vemurafenib monotherapy.

The combination therapy also showed a lower discontinuation rate due to suspected treatment-related adverse events — six percent — compared to vemurafenib’s 14 percent.