This medicine is authorised for use in the European Union.


Xospata is a cancer medicine used to treat adults with acute myeloid leukaemia (AML), a cancer of white blood cells.

Xospata is used when AML has either come back or has not improved following previous treatment and is only given to patients whose cancer cells have a particular change (mutation) in the gene for a protein called FLT3.

The active substance in Xospata is gilteritinib.

AML is rare, and Xospata was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 17 January 2018.

This EPAR was last updated on 18/07/2023

Authorisation details

Product details
Agency product number
Active substance
gilteritinib fumarate
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Leukemia, Myeloid, Acute
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.


This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Astellas Pharma Europe B.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Sylviusweg 62
2333 BE Leiden
The Netherlands

Product information

14/07/2023 Xospata - EMEA/H/C/004752 - IB/0015

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation.

Assessment history

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