Therapeutic Response Statement (Sensitivity)

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

The U.S. Food and Drug Administration granted approval to dabrafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation, as detected by an FDA-approved test.

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

TAFINLAR is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.

Citation

Novartis Pharmaceuticals Corporation. Tafinlar (dabrafenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202806s030lbl.pdf. Revised March 2024. Accessed October 30, 2024.