Regulatory approval

Published by the Health Canada. Approved

ZELBORAF (vemurafenib) is indicated as a monotherapy for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma. A validated test is required to identify BRAF V600 mutation status.

This is written in the approval document.

Citation

Hoffmann-La Roche Limited. Zelboraf (vemurafenib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00054278.PDF. Revised December 2019. Accessed June 2025.

Therapeutic response

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

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
HC (1) BRAF p.V600E Melanoma Vemurafenib
HC (1) BRAF p.V600K Melanoma Vemurafenib

Contributions

Date Contributor Description
2024-10-30 Van Allen lab Initial access of FDA approvals