# Gilteritinib

Gilteritinib (Xospata, Astellas Pharma Europe B.V.) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: FLT3 (1).

## Approved indications

### Acute myeloid leukaemia

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| FLT3 mutation | Monotherapy | 2nd line | Relapsed or refractory |

## Products

### Xospata

- Company: Astellas Pharma Europe B.V.
- Target: FLT3 and AXL inhibitor
- Class: Other protein kinase inhibitors
- ATC: L01EX13
- EU approval: 24 Oct 2019
- Label revised: 9 Jul 2024
- Status: orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/xospata-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/xospata-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/xospata

Mechanism (SmPC section 5.1): Gilteritinib inhibits FLT3 and AXL, blocking FLT3 receptor signalling and cell proliferation, and inducing apoptosis in leukemic cells expressing FLT3-ITD.

## Label wording

- **Gilteritinib** (Xospata), Acute myeloid leukaemia, 2nd line: “Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation (see sections 4.2 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xospata-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/gilteritinib