# Binimetinib

Binimetinib (Mektovi, Pierre Fabre Medicament) has 2 EU-approved indications in 2 tumour types. Each needs a biomarker result: BRAF (2).

## Approved indications

### Non-small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| BRAF V600E | + encorafenib | Advanced | - |

### Melanoma

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

## Products

### Mektovi

- Company: Pierre Fabre Medicament
- Target: MEK1/2 inhibitor
- Class: Mitogen-activated protein kinase (MEK) inhibitors
- ATC: L01EE03
- EU approval: 20 Sep 2018
- Label revised: 5 Nov 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/mektovi-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/mektovi-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/mektovi

Mechanism (SmPC section 5.1): Binimetinib is an ATP-uncompetitive, reversible inhibitor of MEK1 and MEK2 kinase activity that blocks MEK activation by BRAF, suppressing ERK/MAPK pathway signalling and proliferation.

## Label wording

- **Binimetinib** (Mektovi), Melanoma, advanced: “Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/mektovi-epar-product-information_en.pdf)
- **Binimetinib** (Mektovi), Non-small cell lung cancer, advanced: “Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/mektovi-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/binimetinib