Difference between revisions of "Gilteritinib (Xospata)"
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==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
*2019-10-24: Initial authorization | *2019-10-24: Initial authorization | ||
| + | ==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== | == Patient Drug Information== | ||
*[https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211349s001lbl.pdf Gilteritinib (Xospata) Package Insert]<ref>[https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211349s001lbl.pdf Gilteritinib (Xospata) Package Insert]</ref> | *[https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211349s001lbl.pdf Gilteritinib (Xospata) Package Insert]<ref>[https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211349s001lbl.pdf Gilteritinib (Xospata) Package Insert]</ref> | ||
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[[Category:FDA approved in 2018]] | [[Category:FDA approved in 2018]] | ||
[[Category:EMA approved in 2019]] | [[Category:EMA approved in 2019]] | ||
| + | [[Category:PMDA approved in 2018]] | ||
Revision as of 20:33, 8 June 2023
Mechanism of action
Tyrosine kinase inhibitor of FLT3, AXL, and ALK
Diseases for which it is used
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 PMDA indication
- 2018-09-21: New approval for the treatment of relapsed or refractory FLT3 mutation-positive acute myeloid leukemia.
Patient Drug Information
Also known as
- Code name: ASP2215
- Brand name: Xospata