# Cobimetinib

Cobimetinib (Cotellic, Roche Registration GmbH) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: BRAF (1).

## Approved indications

### Melanoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| BRAF V600 | + vemurafenib | Advanced | - |

## Products

### Cotellic

- Company: Roche Registration GmbH
- Target: MEK1/2 inhibitor
- Class: Mitogen-activated protein kinase (MEK) inhibitors
- ATC: L01EE02
- EU approval: 20 Nov 2015
- Label revised: 24 Jun 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/cotellic-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/cotellic-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/cotellic

Mechanism (SmPC section 5.1): Cobimetinib is an allosteric inhibitor of MEK1 and MEK2 that blocks ERK phosphorylation, preventing MAPK pathway-driven cell proliferation.

## Label wording

- **Cobimetinib** (Cotellic), Melanoma, advanced: “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 (see sections 4.4 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/cotellic-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/cobimetinib