Regulatory approval

Published by the Health Canada.

Health Canada approved vemurafenib 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 as:

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.

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.

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Therapeutic response

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

Organization(s) Biomarker(s) Cancer type Therapy(ies)
HC (1) BRAF p.V600E Melanoma Vemurafenib
HC (1) BRAF p.V600K Melanoma Vemurafenib