Xospata
What Xospata is used for
Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation.
Approved use, as published by the European Medicines Agency.
What the labels mean
- Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
Key facts
- Brand
- Xospata
- Active substance
- gilteritinib
- Disease area
- Leukemia, Myeloid, Acute
- Medicine group
- Antineoplastic agents
- ATC code
- L01EX13
- Marketing authorisation holder
- Astellas Pharma Europe B.V.
- Authorised in the EU since
- 2019
Official information
In the USA
Same active substance: Xospata
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Xospata used for?
Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation.
What is the active substance in Xospata?
Xospata contains gilteritinib.
Who makes Xospata?
The EU marketing authorisation holder is Astellas Pharma Europe B.V..
Is Xospata an orphan medicine?
Yes. Xospata is designated an orphan medicine in the EU, for a rare disease (Leukemia, Myeloid, Acute).
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, EU