Olutasidenib
Olutasidenib is a second IDH1 inhibitor for relapsed AML, with a higher response rate in its pivotal cohort than ivosidenib had in its own.
Approved 1 December 2022 for relapsed/refractory IDH1-mutated AML: CR+CRh 35%, median duration 25.9 months in the pivotal cohort (n=147). Developed by Forma Therapeutics, licensed to Rigel. Combination trials with azacitidine and venetoclax, and a frontline study, are ongoing.
1.Binds mutant IDH1 and blocks 2-HG production
- Route
- Oral
- Schedule
- 150 mg twice daily on an empty stomach, until progression (minimum 6 months)
- Monitoring
- Differentiation syndrome (boxed warning), hepatotoxicity, QT
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. IDH1 mutation by an approved test.
- Assistance programmes
- 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
- No UK marketing authorisation as of September 2026, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
- NHS England
- Not routinely funded
Sources: NICE search: olutasidenib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- 1 Dec 2022ApprovalUS
Study 2102-HEM-101 pivotal cohort
Approvals
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
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