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 Health Canada indication== | ||
+ | *2019-12-23: Initial notice of compliance | ||
==History of changes in PMDA indication== | ==History of changes in PMDA indication== | ||
*2018-09-21: New approval for the treatment of relapsed or refractory FLT3 mutation-positive [[acute myeloid leukemia]]. | *2018-09-21: New approval for the treatment of relapsed or refractory FLT3 mutation-positive [[acute myeloid leukemia]]. | ||
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==Also known as== | ==Also known as== | ||
− | *'''Code name:''' | + | *'''Code name:''' ASP-2215 |
*'''Brand name:''' Xospata | *'''Brand name:''' Xospata | ||
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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:Health Canada approved in 2019]] | ||
[[Category:PMDA approved in 2018]] | [[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