Difference between revisions of "Enasidenib (Idhifa)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *2017-08-01: Granted [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm569482.htm FDA regular approval] for the treatment of adult patients with relapsed or refractory [[Acute myeloid leukemia|acute myeloid leukemia]] with an [[Biomarkers#IDH2|isocitrate dehydrogenase-2 (IDH2)]] [[Biomarkers#Alterations|mutation]] as detected by an FDA-approved test. ''(Based on | + | *2017-08-01: Granted [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm569482.htm FDA regular approval] for the treatment of adult patients with relapsed or refractory [[Acute myeloid leukemia|acute myeloid leukemia]] with an [[Biomarkers#IDH2|isocitrate dehydrogenase-2 (IDH2)]] [[Biomarkers#Alterations|mutation]] as detected by an FDA-approved test. ''(Based on AG-221-C-001 relapsed)'' |
==History of changes in Health Canada indication== | ==History of changes in Health Canada indication== | ||
*2019-02-06: Initial notice of compliance with conditions for the treatment of adult patients with relapsed or refractory [[Acute myeloid leukemia|Acute Myeloid Leukemia (AML)]] with an isocitrate dehydrogenase-2 IDH2 mutation. | *2019-02-06: Initial notice of compliance with conditions for the treatment of adult patients with relapsed or refractory [[Acute myeloid leukemia|Acute Myeloid Leukemia (AML)]] with an isocitrate dehydrogenase-2 IDH2 mutation. | ||
Latest revision as of 17:48, 1 August 2023
Mechanism of action
From the NCI Drug Dictionary: An orally available inhibitor of isocitrate dehydrogenase type 2 (IDH2), with potential antineoplastic activity. Upon administration, enasidenib specifically inhibits IDH2 in the mitochondria, which inhibits the formation of 2-hydroxyglutarate (2HG).[1]
Diseases for which it is used
History of changes in FDA indication
- 2017-08-01: Granted FDA regular approval for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test. (Based on AG-221-C-001 relapsed)
History of changes in Health Canada indication
- 2019-02-06: Initial notice of compliance with conditions for the treatment of adult patients with relapsed or refractory Acute Myeloid Leukemia (AML) with an isocitrate dehydrogenase-2 IDH2 mutation.
Patient Drug Information
Also known as
- Code names: AG-221, CC-90007
- Generic name: enasidenib mesylate
- Brand name: Idhifa