# Mirdametinib

Mirdametinib (Ezmekly, Merck Europe B.V. ) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Plexiform neurofibroma (NF1)

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Any line | Symptomatic; inoperable; neurofibromatosis type 1; aged 2 years and above |

## Products

### Ezmekly

- Company: Merck Europe B.V. 
- Target: MEK1/2 inhibitor
- Class: Mitogen-activated protein kinase (MEK) inhibitors
- ATC: L01EE
- EU approval: 17 Jul 2025
- Label revised: 16 Sep 2026
- Status: conditional approval, orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/ezmekly-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/ezmekly-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/ezmekly

Mechanism (SmPC section 5.1): Mirdametinib selectively and non-competitively inhibits MEK1/2, blocking downstream signaling to inhibit tumour cell proliferation and survival.

## Label wording

- **Mirdametinib** (Ezmekly), Plexiform neurofibroma (NF1), any line: “Ezmekly as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric and adult patients with neurofibromatosis type 1 (NF1) aged 2 years and above.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/ezmekly-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/mirdametinib