Difference between revisions of "Gilteritinib (Xospata)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *11 | + | *2018-11-28: 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== | ||
| + | *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== | ||
| + | *[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> | ||
==Also known as== | ==Also known as== | ||
| − | *'''Code name:''' | + | *'''Code name:''' ASP-2215 |
*'''Brand name:''' Xospata | *'''Brand name:''' Xospata | ||
| + | |||
| + | ==References== | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
| Line 16: | Line 27: | ||
[[Category:Mutation-specific medications]] | [[Category:Mutation-specific medications]] | ||
| − | [[Category: | + | [[Category:Acute myeloid leukemia medications]] |
| + | |||
[[Category:ALK inhibitors]] | [[Category:ALK inhibitors]] | ||
[[Category:AXL inhibitors]] | [[Category:AXL inhibitors]] | ||
| Line 22: | Line 34: | ||
[[Category:FDA approved in 2018]] | [[Category:FDA approved in 2018]] | ||
| + | [[Category:EMA approved in 2019]] | ||
| + | [[Category:Health Canada approved in 2019]] | ||
| + | [[Category:PMDA approved in 2018]] | ||
Latest revision as of 18:41, 14 August 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 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
Also known as
- Code name: ASP-2215
- Brand name: Xospata