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 Anaplastic Thyroid Cancer.
The U.S. Food and Drug Administration granted approval to dabrafenib in combination with trametinib for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation, as detected by an FDA-approved test, and with no satisfactory locoregional treatment options.
This statement is based on a regulatory approval from the Food and Drug Administration:
MEKINIST is indicated, in combination with dabrafenib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options.