Ivosidenib
Ivosidenib is a pill that blocks the mutant IDH1 enzyme, approved in bile duct cancer and in leukaemia.
ClarIDHy: PFS 2.7 vs 1.4 months (HR 0.37) and crossover-adjusted OS benefit in IDH1-mutant cholangiocarcinoma; approved August 2021. Also approved in IDH1-mutant AML (first line with azacitidine) and MDS. Modest response rate (2%); disease stabilisation is the benefit.
1.Mutant IDH1 converts α-ketoglutarate to the oncometabolite 2-HG
- Route
- Oral
- Schedule
- 500 mg daily
- Monitoring
- QT interval, differentiation syndrome (AML)
- 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. IDH1 mutation by an approved test.
- Assistance programmes
- ServierONE
- 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
- Licensed 2023 for IDH1-mutated cholangiocarcinoma and with azacitidine for IDH1-mutated AML; NICE recommended the cholangiocarcinoma indication in 2024. TA number not verified.
Sources: NICE search: ivosidenib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- 20 Jul 2018ApprovalUS
First IDH1 inhibitor
- 25 May 2022ApprovalUS
Combination with azacitidine (AGILE)
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2018 | Relapsed/refractory IDH1-mutant AML |
| US | 2021 | Previously treated IDH1-mutant cholangiocarcinoma |
| US | 2018 | Relapsed/refractory IDH1-mutated AML |
| US | 2019 | Newly diagnosed IDH1-mutated AML unfit for intensive chemotherapy |
| US | 2021 | Previously treated IDH1-mutated cholangiocarcinoma |
| US | 2022 | Newly diagnosed IDH1-mutated AML with azacitidine (AGILE) |
| US | 2023 | Relapsed/refractory IDH1-mutated MDS |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Nausea ClarIDHy | 41% | — |
| Diarrhoea | 35% | — |
| Fatigue | 31% | — |
| Ascites | — | 9% |
| Differentiation syndrome AGILE combination arm | 14% | — |
| QT prolongation | 20% | — |
| Neutropenia with azacitidine | — | 27% |
| Leukocytosis | 12% | — |
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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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Ivosidenib" OR ABSTRACT:"Ivosidenib" OR TITLE:"Tibsovo" OR ABSTRACT:"Tibsovo") 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 Ivosidenib, not a curated reading list.
Pages like this
not linked directly; found by shared links- ProductEnasidenib
Shares Differentiation syndrome, IDH1 / IDH2, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET), Acute myeloid leukaemia.
- ProductVorasidenib
Shares Servier, Glutamine addiction, IDH1 / IDH2, Cancer metabolism.
- ProductOlutasidenib
Shares Differentiation syndrome, IDH1 / IDH2, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET), Acute myeloid leukaemia.
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Shares Differentiation syndrome, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET), Acute myeloid leukaemia.
- TermHallmark: reprogramming cellular metabolism
Shares Glutamine addiction, IDH1 / IDH2, Cancer metabolism.
- Key paperINDIGO: vorasidenib, the first targeted drug for IDH-mutant low-grade glioma
Shares Servier, IDH1 / IDH2, Small-molecule kinase inhibitors.
- ProductAsparaginase (pegaspargase, calaspargase pegol, Erwinia asparaginase)
Shares Servier, Glutamine addiction.