Enasidenib
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 The phase 3 IDHENTIFY trial did not improve OS versus conventional care; the EMA application was withdrawn (2019), and BMS later announced market withdrawal in some territories while maintaining US availability.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.
1.Mutant IDH2 produces 2-HG in mitochondria
- Route
- Oral
- Schedule
- 100 mg once daily until progression (minimum 6 months)
- Monitoring
- Differentiation syndrome (boxed warning), bilirubin (indirect hyperbilirubinaemia from UGT1A1 inhibition)
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
- Medicare
- Part D (self-administered)
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).
- Commercial insurance
- covered with prior authorisation
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.
- Assistance programmes
- BMS Access Support
- Bristol Myers Squibb Patient Assistance Foundation
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
- Leukemia & Lymphoma Society financial support
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.
- Notes
- EU marketing authorisation application withdrawn 2019; no UK licence.
- NHS England
- Not routinely funded
Sources: NICE search: enasidenib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- 1 Aug 2017ApprovalUS
Single-arm AG221-C-001
- 1 Dec 2019WithdrawalEU
Marketing application withdrawn after EMA objections on efficacy source
Approvals
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- ProductOlutasidenib
Shares Differentiation syndrome, IDH1 / IDH2, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET), Acute myeloid leukaemia.
- ProductTretinoin (all-trans retinoic acid, ATRA)
Shares Differentiation syndrome, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET), Acute myeloid leukaemia.
- ProductArsenic trioxide
Shares Differentiation syndrome, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET), Acute myeloid leukaemia.
- ProductIvosidenib
Shares Differentiation syndrome, IDH1 / IDH2, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET), Acute myeloid leukaemia.
- PersonTimothy J. Ley
Shares IDH1 / IDH2, Acute myeloid leukaemia.
- PersonChristopher R. Vakoc
Shares Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET), Acute myeloid leukaemia.
- TrialAGILE
Shares IDH1 / IDH2, Acute myeloid leukaemia.
- PersonStephen B. Baylin
Shares Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET), Acute myeloid leukaemia.