Gilteritinib
Gilteritinib (Xospata, Astellas Pharma Europe B.V.) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: FLT3 (1).
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Acute myeloid leukaemia1 | |||
FLT3 mutation | Monotherapy | 2L | Relapsed or refractory |
Full text of section 4.1 (therapeutic indications)
Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation (see sections 4.2 and 5.1).
Label history
5 changes to the Xospata label since 2021, none of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes