Regulatory approval

Published by the Food and Drug Administration. Approved

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.

This is written in the approval document.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	BRAF p.V600E	Melanoma	Dabrafenib, Trametinib
FDA (2)	BRAF p.V600K	Melanoma	Dabrafenib, Trametinib

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2018-04-30	Food and Drug Administration	Indication received traditional approval.