Cotellic (cobimetinib) [product information]. EMA.
Regulatory approval published by the European Medicines Agency.
Citation
Roche Registration GmbH. Cotellic (cobimetinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/cotellic-epar-product-information_en.pdf. Revised March 2023. Accessed March 6, 2024.Regulatory approvals
Approved indications from this document for cancer drugs containing at least one biomarker.
| Indication | Statements |
|---|---|
| Cotellic is indicated for use in combination with vemurafenib for the treatment of adult 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 |