Therapeutic Response

BRAF p.V600E status confers therapeutic sensitivity to Dabrafenib in patients with Melanoma.

Statements

Source and description
Dabrafenib Monotherapy. NCCP National SACT Regimen. HSE. The Republic of Ireland's Health Service Executive (HSE) has approved dabrafenib for reimbursement as a treatment option for the treatment of adults with unresectable or metastatic melanoma that harbor a BRAF V600 mutation.
Tafinlar (dabrafenib) [product information]. EMA. The European Medicines Agency (EMA) has authorized dabrafenib as a monotherapy or in combination with trametinib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 variant.
Tafinlar (dabrafenib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to dabrafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation, as detected by an FDA-approved test.