Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that BRAF p.V600E status confers therapeutic sensitivity to Dabrafenib, Trametinib in patients with Melanoma.

This statement is based on a regulatory approval from the Food and Drug Administration:

MEKINIST is indicated, in combination with dabrafenib, 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.

Citation

Novartis Pharmaceuticals Corporation. Mekinist (trametinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217513s003lbl.pdf. Revised March 2024. Accessed October 30, 2024.