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olutasidenib (Rezlidhia)
Indications:
- treatment adults with relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation as detected by an FDA-approved test
Dose:
- 150 mg PO BID
Adverse effects:
- common 20%
- nausea, fatigue/malaise, arthralgia, constipation, leukocytosis, dyspnea, fever, rash, mucositis, diarrhea elevated serum ALT & serum AST
* boxed warning for risk of differentiation syndrome
Laboratory:
- Abbott RealTime IDH1 Assay is accompanying FDA-approved test
Mechanism of action:
- binds to & inhibits mutated IDH1 to reduce 2-hydroxyglutarate levels & restore normal cellular differentiation of myeloid cells
- about 1/3 of patients achieve complete remission in 1-6 months (median 2 months)
General
small inhibitory antineoplastic agent (ib drug)
Database Correlations
PUBCHEM cid=118955396
References
- Shinkle M
Healio: HemOnc today. Dec 2, 2022
https://www.healio.com/news/hematology-oncology/20221202/fda-approves-olutasidenib-for-certain-adults-with-acute-myeloid-leukemia
- FDA approves olutasidenib for relapsed or refractory acute myeloid leukemia
with a susceptible IDH1 mutation (press release) Dec 1, 2022
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-olutasidenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-idh1-mutation