Basic Information
Xospata
Regulatory Information
EMEA/H/C/004752
October 24, 2019
September 19, 2019
7
July 9, 2024
Company Information
the netherlands
Sylviusweg 62 2333 BE Leiden
ASTELLAS PHARMA EUROPE B.V.
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### 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.
Overview Summary
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.