New oral treatment for metastatic melanoma receives EU authorisation

Encorafenib in combination with binimetinib demonstrated 14.9 months median progression-free survival compared with vemurafenib monotherapy (7.3 months).

The European Commission (EC) has granted Pierre Fabre marketing authorisation for Braftovi (encorafenib) and Mektovi (binimetinib) in combination for the treatment of adult patients with unresectable or metastatic melanoma with a BRAFV600 mutation, as detected by a validated test.

The EU licence is based on Phase III COLUMBUS trial that demonstrated 14.9 months median progression-free survival (PFS) versus vemurafenib monotherapy (7.3 months).

Encorafenib in combination with binimetinib also showed a lower discontinuation rate due to suspected treatment-related adverse events (AEs) (6%) compared to vemurafenib (14%).

Dr James Larkin, Consultant Medical Oncologist, The Royal Marsden NHS Foundation Trust, commented: "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 and today’s milestone is great news for melanoma patients, and clinicians and nurses that care for them."