Regulatory approval

Published by the Food and Drug Administration. Approved

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.

This is written in the approval document.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	BRAF p.V600E	Melanoma	Vemurafenib

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.