Regulatory approval

Published by the Food and Drug Administration. Approved

MEKTOVI is a kinase inhibitor indicated in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.

This is written in the approval document.

Citation

Array BioPharma, Inc. Mektovi (binimetinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210498s009lbl.pdf. Revised October 2023. 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	Binimetinib, Encorafenib
FDA (2)	BRAF p.V600K	Melanoma	Binimetinib, Encorafenib

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2018-06-27	Food and Drug Administration	Indication received traditional approval.