Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration granted approval to vemurafenib for the treatment of patients with Erdheim-Chester Disease and a BRAF V600 mutation.

This is written in the approval document as:

ZELBORAF is indicated for the treatment of patients with Erdheim-Chester Disease with BRAF V600 mutation.

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	Erdheim-Chester Disease	Vemurafenib
FDA (2)	BRAF p.V600K	Erdheim-Chester Disease	Vemurafenib

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2017-11-06	Food and Drug Administration	Indication received traditional approval.