Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that BRAF p.V600E status confers therapeutic sensitivity to Binimetinib, Encorafenib in patients with Non-Small Cell Lung Cancer.

The U.S. Food and Drug Administration granted approval to binimetinib 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.

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 adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E 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/2023/210498s009lbl.pdf. Revised October 2023. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2023-10-11	Food and Drug Administration	Indication received traditional approval.