# Selumetinib

Selumetinib (Koselugo, AstraZeneca AB) has 2 EU-approved indications in 1 tumour type.

## Approved indications

### Plexiform neurofibroma (NF1)

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Any line | Symptomatic; inoperable; neurofibromatosis type 1 (NF1); aged 3 years and older |
| None | Monotherapy | Any line | Symptomatic; inoperable; neurofibromatosis type 1 (NF1); aged 1 year to less than 7 years, or older patients with swallowing difficulties |

## Products

### Koselugo

- Company: AstraZeneca AB
- Target: Selective MEK1/2 inhibitor
- Class: Mitogen-activated protein kinase (MEK) inhibitors
- ATC: L01EE04
- EU approval: 17 Jun 2021
- Label revised: 15 Oct 2026
- Status: conditional approval, orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/koselugo-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/koselugo-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/koselugo

Mechanism (SmPC section 5.1): Selumetinib selectively inhibits MEK1/2, blocking MEK activity and the RAF-MEK-ERK pathway. This can block proliferation and survival of tumour cells in which that pathway is activated.

## 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)

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/selumetinib