# Plexiform neurofibroma (NF1)

The EU has approved 3 indications of 2 drugs in plexiform neurofibroma (NF1). None of them needs a biomarker result.

## Approved indications

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Mirdametinib](https://oncolabels.com/drugs/mirdametinib) (Ezmekly) | None | Monotherapy | Any line | Symptomatic; inoperable; neurofibromatosis type 1; aged 2 years and above |
| [Selumetinib](https://oncolabels.com/drugs/selumetinib) (Koselugo) | None | Monotherapy | Any line | Symptomatic; inoperable; neurofibromatosis type 1 (NF1); aged 3 years and older |
| [Selumetinib](https://oncolabels.com/drugs/selumetinib) (Koselugo) | None | Monotherapy | Any line | Symptomatic; inoperable; neurofibromatosis type 1 (NF1); aged 1 year to less than 7 years, or older patients with swallowing difficulties |

## Label wording

- **Selumetinib** (Koselugo), Plexiform neurofibroma (NF1), any line: “Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adult and paediatric patients with neurofibromatosis type 1 (NF1) aged 3 years and older.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/koselugo-epar-product-information_en.pdf)
- **Selumetinib** (Koselugo), Plexiform neurofibroma (NF1), any line: “Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in patients with neurofibromatosis type 1 (NF1) aged 1 year to less than 7 years and for older patients with swallowing difficulties.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/koselugo-epar-product-information_en.pdf)
- **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/tumours/plexiform-neurofibroma-nf1