Difference between revisions of "Enasidenib (Idhifa)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *8/1/2017: 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)'' | + | *8/1/2017: 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 [https://clinicaltrials.gov/ct2/show/NCT01915498 AG-221-C-001])'' |
== Patient Drug Information== | == Patient Drug Information== | ||
Revision as of 13:27, 20 April 2021
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
- 8/1/2017: 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)
Patient Drug Information
Also known as
- Code names: AG-221, CC-90007
- Generic name: enasidenib mesylate
- Brand name: Idhifa