Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that BRAF p.V600K status confers therapeutic sensitivity to Binimetinib, Encorafenib in patients with Melanoma.

The U.S. Food and Drug Administration granted approval to binimetinib 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 statement is based on a regulatory approval from the Food and Drug Administration:

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.

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. Array BioPharma, Inc. Mektovi (binimetinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210498lbl.pdf. Revised June 2018. Accessed October 6, 2026.

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.