Olutasidenib monotherapy (R/R IDH1-mutant AML, post-induction consolidation/maintenance)
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
Knowledge-base record for audit. Provisional clinical content: this is not a prescription. An oncologist must verify original sources, applicability and review status. Full rules and constraints are in the YAML.
| Components | DRUG-OLUTASIDENIB |
|---|
| ID | REG-OLUTASIDENIB-AML-IDH1-CONSOLIDATION |
|---|---|
| Type | Regimen |
| Status | reviewed 2026-04-29 | pending_clinical_signoff |
| Diseases | None declared |
| Sources | SRC-NCCN-AML-2025 |
Notes
Selective IDH1 inhibitor for R/R IDH1-mutant AML in adults. Pivotal Study 2102-HEM-101 (single-arm, n=153, R/R IDH1-mut AML, olutasidenib 150 mg PO BID) — CR + CRh 35%; mDOR 25.9 mo (CR/CRh subgroup); transfusion independence 56-month; ~30% transitioned to allo-HSCT. Compares favorably to ivosidenib (alternative IDH1 inhibitor — separate regimen entity, future). BOXED WARNINGS: differentiation syndrome (~16%) + hepatotoxicity (~21% Grade ≥3 transaminitis). Used as bridge to allo-HSCT in fit patients. Ivosidenib + azacitidine combination (AGILE trial, newly-diagnosed unfit IDH1-mut AML) is a separate regimen entity. STUB — pending Study 2102-HEM-101 trial Source ingestion (SRC-OLUTASIDENIB-DEBOTTON-2023) and Co-Lead sign-off.
Used By
No reverse references found in the YAML corpus.