Therapeutic Response

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

Statements

Source and description
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.
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 and adolescent patients aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 variant.