Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that BRAF p.V600K status confers therapeutic sensitivity to Dabrafenib, Trametinib in patients with Melanoma.
The U.S. Food and Drug Administration granted approval to dabrafenib in combination with trametinib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test.
This statement is based on a regulatory approval from the Food and Drug Administration:
TAFINLAR is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.