Xospata (gilteritinib)
Orphan
- Region
- 🇪🇺 EU
- Active substance
- gilteritinib
- Company
- Astellas Pharma Europe B.V.
- Status
- Authorised
- Therapeutic area
- Leukemia, Myeloid, Acute
- CHMP opinion
- Thu 19 Sep 2019
- EU approval
- Thu 24 Oct 2019
- Designations
- Orphan
- Application
- EMEA/H/C/004752
- ATC
- L01EX13
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.