Difference between revisions of "Gilteritinib (Xospata)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
*11/28/2018: Initial FDA approval for treatment of adult patients who have relapsed or refractory [[Acute_myeloid_leukemia|acute myeloid leukemia (AML)]] with a [[Biomarkers#FLT3|FLT3]] [[Biomarkers#Alterations|mutation]] as detected by an FDA-approved test. ''(Based on ADMIRAL)'' | *11/28/2018: Initial FDA approval for treatment of adult patients who have relapsed or refractory [[Acute_myeloid_leukemia|acute myeloid leukemia (AML)]] with a [[Biomarkers#FLT3|FLT3]] [[Biomarkers#Alterations|mutation]] as detected by an FDA-approved test. ''(Based on ADMIRAL)'' | ||
| − | + | ==History of changes in EMA indication== | |
| + | *10/24/2019: Initial authorization | ||
== 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]] | ||
Revision as of 20:50, 1 January 2023
Mechanism of action
Tyrosine kinase inhibitor of FLT3, AXL, and ALK
Diseases for which it is used
History of changes in FDA indication
- 11/28/2018: 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
- 10/24/2019: Initial authorization
Patient Drug Information
Also known as
- Code name: ASP2215
- Brand name: Xospata