The European Commission (EC) has granted marketing authorisation for Pierre Fabre’s Braftovi and Mektovi combination therapy for the treatment of adults with unresectable or metastatic melanoma with a BRAFV600 mutation.

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.

Inappropriate activation of proteins in this pathway has been shown to occur in many cancers, including melanoma, colorectal cancer, non-small-cell lung cancer, thyroid and others, the firm noted.

Approval of the combination rides on the back of data from the Phase III COLUMBUS trial, which showed 14.9 months of median progression-free survival (PFS) with the combination versus vemurafenib monotherapy (7.3 months).

Braftovi/Mektovi also showed a lower discontinuation rate due to suspected treatment-related adverse events (6%) compared to vemurafenib (14%), the firm 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,” commented Dr James Larkin, consultant medical oncologist, at The Royal Marsden NHS Foundation Trust.

“The COLUMBUS trial has demonstrated the compelling benefits of encorafenib in combination with binimetinib,” and the approval “is great news for melanoma patients, and clinicians and nurses that care for them.”