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Xospata
Published
Product name
Xospata
Active ingredient
Gilteritinib (as fumarate)
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Xospata (gilteritinib (as fumarate)) was approved for the following therapeutic use:
Xospata is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation.
How this medicine works
Gilteritinib fumarate is a FMS-like tyrosine kinase 3 (FLT3) and AXL (as well as other kinases) inhibitor. Gilteritinib inhibits FLT3 receptor signalling and proliferation in cells expressing FLT3 including FLT3-internal tandem duplication (ITD), FLT3-D835Y, and FLT3-ITD-D835Y, and it induced apoptosis in leukaemic cells expressing FLT3-ITD.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Xospata was considered favourable for the therapeutic use approved.