Therapeutic Response

BRAF p.V600E status confers therapeutic sensitivity to Dabrafenib in combination with Trametinib in patients with Any solid tumor.

Statements

Source and description
Mekinist (trametinib) [package insert]. FDA. The U.S. Food and Drug Administration granted accelerated approval to trametinib in combination with dabrafenib for the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. The product label specifies that this indication is approved under accelerated approval based on overall response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Furthermore, the product label states a Limitation of Use: trametinib is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition.
Tafinlar (dabrafenib) [package insert]. FDA. The U.S. Food and Drug Administration granted accelerated approval to dabrafenib in combination with trametinib for the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options.