Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that BRAF p.V600E status confers therapeutic sensitivity to Binimetinib, Encorafenib in patients with Melanoma.
The European Medicines Agency (EMA) has authorized encorafenib in combination with binimetinib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 variant. The efficacy and safety of encorafenib have been established only in patients with melanoma tumours expressing BRAF V600E and V600K variants or colorectal tumours expressing BRAF V600E.
This statement is based on a regulatory approval from the European Medicines Agency:
Encorafenib is indicated in combination with binimetinib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.