Zelboraf (vemurafenib) [product monograph]. HC.

Regulatory approval published by the Health Canada.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	BRAF p.V600E	Melanoma	Vemurafenib
Sensitivity (+)	BRAF p.V600K	Melanoma	Vemurafenib