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.

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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 Cobimetinib, Vemurafenib
HC (1) BRAF p.V600K Melanoma Cobimetinib, Vemurafenib