Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that BRAF p.V600E status confers therapeutic sensitivity to Vemurafenib in patients with Melanoma.

The U.S. Food and Drug Administration granted approval to vemurafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation, as detected by an FDA-approved test.

This statement is based on a regulatory approval from the Food and Drug Administration:

ZELBORAF is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.

Citation

Genentech, Inc. Zelboraf (vemurafenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202429s019lbl.pdf. Revised May 2020. Accessed October 30, 2024. Genentech, Inc. Zelboraf (vemurafenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202429s000lbl.pdf. Revised August 2011. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2011-08-17	Food and Drug Administration	Indication received traditional approval.