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Enasidenib is the IDH2 counterpart of ivosidenib, approved in the US for relapsed disease but never approved in Europe after it failed to extend survival in a confirmatory trial.
Approved 2017 (US) for relapsed/refractory IDH2-mutated AML on a single-arm study (CR+CRh ~23%). The phase 3 IDHENTIFY trial did not improve OS versus conventional care; the EMA application was withdrawn (2019), and BMS later announced market withdrawal in some territories while maintaining US availability. Illustrates the gap between response rate and survival endpoints in relapsed AML.
Allosteric inhibitor of mutant IDH2 (R140Q and R172K), lowering 2-HG and inducing differentiation. Connects to IDH1 / IDH2.
1.Mutant IDH2 produces 2-HG in mitochondria
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. IDH2 mutation by an approved test.
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
Sources: NICE search: enasidenib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Single-arm AG221-C-001
Marketing application withdrawn after EMA objections on efficacy source
| Region | Year | Indication |
|---|---|---|
| US | 2017 | Relapsed/refractory IDH2-mutated AML |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Differentiation syndrome | 14% | - |
| Indirect hyperbilirubinaemia | 81% | - |
| Nausea | 50% | - |
Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
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IDH2 mutations, present in about one in eight AML cases, became actionable. Enasidenib is an option at relapse; its role in newly diagnosed disease is less established than ivosidenib's.
Sinonasal undifferentiated carcinoma can be confirmed by IDH2 testing or mutant-IDH immunohistochemistry rather than diagnosed by exclusion, and IDH2 inhibitors such as enasidenib became rational candidates for trials.
Query for this drug: (TITLE:"Enasidenib" OR ABSTRACT:"Enasidenib" OR TITLE:"Idhifa" OR ABSTRACT:"Idhifa") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Enasidenib, not a curated reading list.
Shares Mutant IDH / 2-hydroxyglutarate, Differentiation syndrome, IDH inhibitors, IDH1- and IDH2-mutated acute myeloid leukaemia.
Shares IDH inhibitors, IDH1- and IDH2-mutated acute myeloid leukaemia, IDH1 / IDH2, Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome.
Shares Mutant IDH / 2-hydroxyglutarate, IDH1- and IDH2-mutated acute myeloid leukaemia, IDH1 / IDH2, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET).
Shares Mutant IDH / 2-hydroxyglutarate, Differentiation syndrome, IDH inhibitors, Beat AML Master Trial.
Shares IDH1- and IDH2-mutated acute myeloid leukaemia, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET), Bristol Myers Squibb, Acute myeloid leukaemia.
Shares IDH inhibitors, IDH1 / IDH2, Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET).
Shares Mutant IDH / 2-hydroxyglutarate, IDH inhibitors, IDH1 / IDH2, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET).
Shares IDH2 mutation (R140 and R172), Mutant IDH / 2-hydroxyglutarate, IDH inhibitors, IDH1 / IDH2.