Enasidenib (Idhifa)
Revision as of 15:45, 31 May 2023 by Warner-admin (talk | contribs) (Text replacement - "(NCT[0-9]{8})" to "[https://clinicaltrials.gov/ct2/show/$1 Clinical Trial Registry]")
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 [https://clinicaltrials.gov/ct2/show/NCT01915498 Clinical Trial Registry 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