Gilteritinib (Xospata)

Mechanism of action

Tyrosine kinase inhibitor of FLT3, AXL, and ALK

Diseases for which it is used

• FLT3+ AML

History of changes in FDA indication

• 2018-11-28: Initial FDA approval for treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. (Based on ADMIRAL)

History of changes in EMA indication

• 2019-10-24: Initial authorization

History of changes in Health Canada indication

• 2019-12-23: Initial notice of compliance

History of changes in PMDA indication

• 2018-09-21: New approval for the treatment of relapsed or refractory FLT3 mutation-positive acute myeloid leukemia.

Patient Drug Information

• Gilteritinib (Xospata) Package Insert

Also known as

• Code name: ASP-2215
• Brand name: Xospata