Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to trametinib for the treatment of BRAF-inhibitor treatment-naive patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test.

This is written in the approval document as:

MEKINIST is a kinase inhibitor indicated as a single agent for the treatment of BRAF-inhibitor treatment-naive patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.

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.

Therapeutic response

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

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	BRAF p.V600E	Melanoma	Trametinib
Sensitivity (+)	BRAF p.V600K	Melanoma	Trametinib