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.