Regulatory approval

Published by the Food and Drug Administration. Approved

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

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.

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Therapeutic response

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

Organizations
Biomarkers
Cancer types
Therapies
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.