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Olutasidenib is a second IDH1 inhibitor for relapsed AML, with a higher response rate in its pivotal cohort than ivosidenib had in its own.
Olutasidenib is a selective, allosteric inhibitor of mutant IDH1 that lowers the oncometabolite 2-hydroxyglutarate and lets blocked myeloid cells differentiate. It was approved on 1 December 2022 for relapsed or refractory IDH1-mutated AML, taken twice daily for a minimum of 6 months. In the pivotal cohort (n=147) the CR plus CRh rate was 35% with a median duration of 25.9 months, higher than ivosidenib achieved in its own pivotal cohort, although the two were not compared directly. Differentiation syndrome (16%) carries a boxed warning, and liver enzymes and QT are monitored. Forma Therapeutics developed it and licensed it to Rigel, and combination trials with azacitidine and venetoclax, and a frontline study, are ongoing. It is a second pill for the same genetic subtype of AML, working by switching differentiation back on rather than killing cells.
Selective, allosteric mutant-IDH1 inhibitor lowering 2-HG. Connects to IDH1 / IDH2.
1.Binds mutant IDH1 and blocks 2-HG production
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. IDH1 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: olutasidenib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Study 2102-HEM-101 pivotal cohort
| Region | Year | Indication |
|---|---|---|
| US | 2022 | Relapsed/refractory IDH1-mutated AML |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Differentiation syndrome | 16% | - |
| Transaminase elevation | 23% | - |
| Nausea | 38% | - |
Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
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Query for this drug: (TITLE:"Olutasidenib" OR ABSTRACT:"Olutasidenib" OR TITLE:"Rezlidhia" OR ABSTRACT:"Rezlidhia") 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 Olutasidenib, 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 IDH1 R132 mutation, IDH1- and IDH2-mutated acute myeloid leukaemia, Astrocytoma, IDH-mutant (grades 2 to 4), IDH1 / IDH2.
Shares Mutant IDH / 2-hydroxyglutarate, IDH inhibitors, Astrocytoma, IDH-mutant (grades 2 to 4), IDH1 / IDH2.
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, IDH1 R132 mutation, IDH inhibitors, Astrocytoma, IDH-mutant (grades 2 to 4).
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, Differentiation syndrome, IDH1 R132 mutation, IDH inhibitors.