Therapeutic Response

BRAF p.V600E status confers therapeutic sensitivity to Binimetinib in combination with Encorafenib in patients with Melanoma.

Statements

Source and description
Braftovi (encorafenib) [product information]. EMA. 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.
Mektovi (binimetinib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to binimetinib in combination with encorafenib for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
Encorafenib and Binimetinib Therapy. NCCP National SACT Regimen. HSE. The Republic of Ireland's Health Service Executive (HSE) has approved encorafenib in combination with binimetinib for reimbursement as a treatment option for the treatment of adult patients with advanced (unresectable or metastatic) melanoma with a BRAF V600 mutation.
Braftovi (encorafenib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to encorafenib in combination with binimetinib for the treatment of unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. Encorafenib's package insert further states that it is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF colorectal cancer, or wild-type BRAF non-small cell lung cancer.
Mektovi (binimetinib) [product information]. EMA. The European Medicines Agency (EMA) has authorized binimetinib in combination with encorafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.