Regulatory approval

Published by the Health Canada.

Health Canada approved cobimetinib in combination wih vemurafenib for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

This is written in the approval document as:

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.

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.

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