Cotellic (cobimetinib) [product monograph]. HC.

Regulatory approval published by the Health Canada.

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.

Regulatory approvals

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

Indication Statements
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. 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 Cobimetinib, Vemurafenib
Sensitivity (+) BRAF p.V600K Melanoma Cobimetinib, Vemurafenib