Mektovi (binimetinib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	2
MEKTOVI is a kinase inhibitor indicated in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
FDA (1)	BRAF p.V600E	Melanoma	Binimetinib, Encorafenib
FDA (1)	BRAF p.V600K	Melanoma	Binimetinib, Encorafenib
FDA (1)	BRAF p.V600E	Non-Small Cell Lung Cancer	Binimetinib, Encorafenib