Regulatory approval

Published by the Health Canada. Approved

COTELLIC (cobimetinib) is indicated for use in combination with vemurafenib for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

This is written in the approval document.

Citation

Hoffmann-La Roche Limited. Cotellic (cobimetinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00070061.PDF. Revised March 2023. Accessed June 2025.

Therapeutic response

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

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

Contributions

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