Xospata
gilteritinib
Table of contents
Overview
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.
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Xospata : EPAR - Medicine overview (PDF/107.62 KB)
First published: 08/11/2019
EMA/526415/2019 -
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Xospata : EPAR - Risk-management-plan summary (PDF/115.41 KB)
First published: 08/11/2019
Last updated: 18/07/2023
Authorisation details
Product details | |
---|---|
Name |
Xospata
|
Agency product number |
EMEA/H/C/004752
|
Active substance |
gilteritinib fumarate
|
International non-proprietary name (INN) or common name |
gilteritinib
|
Therapeutic area (MeSH) |
Leukemia, Myeloid, Acute
|
Anatomical therapeutic chemical (ATC) code |
L01EX13
|
Additional 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. |
Orphan |
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 | |
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Marketing-authorisation holder |
Astellas Pharma Europe B.V.
|
Revision |
4
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Date of issue of marketing authorisation valid throughout the European Union |
24/10/2019
|
Contact address |
Sylviusweg 62 |
Product information
14/07/2023 Xospata - EMEA/H/C/004752 - IB/0015
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.