Braftovi and Mektovi combination win EU approval for metastatic melanoma

Pierre Fabre’s Braftovi (encorafenib) is an oral small-molecule BRAF kinase inhibitor and Mektovi (binimetinib) is an oral small-molecule MEK inhibitor that targets key enzymes in the MAPK signalling pathway. This combination therapy for the treatment of adults with unresectable or metastatic melanoma with a BRAFV600 mutation has been approved for market by the European Commission.
Phase III COLUMBUS trial data showed the encorafenib/binimetinib combination has a median progression-free survival rate of 14.9 months in comparison with vemurafenib monotherapy which has a PFS rate of 7.3 months. At 6%, the combination therapy also showed a lower discontinuation rate due to suspected treatment-related adverse events versus 14% for vemurafenib monotherapy.
Dr James Larkin, consultant medical oncologist at The Royal Marsden NHS Foundation Trust, said: “Despite significant improvements in the past decade, there is still a need for efficacious options for adults with unresectable or metastatic melanoma with a BRAF V600 mutation. The COLUMBUS trial has demonstrated the compelling benefits of encorafenib in combination with binimetinib.”