Therapeutic Response

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

Statements

Source and description
Mekinist (trametinib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to trametinib for the treatment of BRAF-inhibitor treatment-naive patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test.
Mekinist (trametinib) [product information]. EMA. The European Medicines Agency (EMA) has authorized trametinib as a monotherapy or in combination with dabrafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 variant. Trametinib's product information further states that trametinib as a monotherapy has not demonstrated clinical activity in patients who have progressed on prior BRAF inhibitor therapy.