Pierre Fabre has announced that the European Commission (EC) has granted 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 EC decision is based on results from the Phase 3 COLUMBUS trial. This trial demonstrated that the combination of encorafenib 450mg daily and binimetinib 45mg twice daily improved median PFS (primary endpoint), compared with vemurafenib alone 960mg twice daily (14.9 months versus 7.3 months). Treatment with BRAFTOVI and MEKTOVI achieved a median overall survival (OS) of 33.6 months, compared with 16.9 months for patients treated with vemurafenib as a monotherapy in the planned analysis of OS in the COLUMBUS trial.
The most common adverse reactions (>25%) occurring in patients treated with BRAFTOVI and administered with MEKTOVI at the recommended dose were fatigue, nausea, diarrhoea, vomiting, retinal detachment, abdominal pain, arthralgia, increased blood creatine kinase and myalgia. In the COLUMBUS trial, AEs leading to discontinuation that were suspected to be related to the study treatment occurred in 6% of patients vs 14% for vemurafenib alone.
In June 2018, Pierre Fabre’s partner Array BioPharma, which has exclusive rights for these medicines in the United States (US), announced that the combination of BRAFTOVI and MEKTOVI was approved by the Food and Drug Administration (FDA) in the US for the treatment of unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test.4,5 BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma.
Dr James Larkin, Consultant Medical Oncologist, 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 and today’s milestone is great news for melanoma patients, and clinicians and nurses that care for them.”
Laura McMullin, General Manager UK & Ireland, Pierre Fabre said, “This marketing authorisation brings us closer to allowing metastatic melanoma patients in the UK access to a new, oral medication that demonstrated both a superior progression-free survival and lower discontinuation rates due to suspected treatment-related adverse events compared to vemurafenib alone. Pierre Fabre is proud to be taking steps to support the melanoma community and we look forward to collaborating with NICE and progressing in the approval journey in the UK.”