Drug updated on 4/18/2024
| Dosage Form | Capsule (oral; 150 mg) |
| Drug Class | Isocitrate dehydrogenase-1 inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.
Summary
- Olutasidenib (Rezlidhia) is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.
- The study was derived from a randomized controlled trial that focused on the safety and effectiveness of olutasidenib in treating AML.
- The study included both genders and mostly white participants aged 18 years or older. It specifically involved adults carrying IDH1 mutations, indicating its targeted therapy approach. The effectiveness among different risk groups of myelodysplastic syndrome and across various demographic groups within the context of relapsed or refractory AML was outlined.
- In terms of dosing, evaluated doses were 150 mg once daily, 150 mg twice a day, and 300 mg once daily for olutasidenib. No dose-limiting toxicities were identified; the dosage recommended for phase two based on safety considerations was 150 mg twice per day.
- Safety findings showed no dose-limiting toxicities, while grade three to four treatment-emergent adverse events included thrombocytopenia, febrile neutropenia, and anemia in both monotherapy and combination therapy settings. Deaths occurred mainly due to disease progression rather than being related to the drug itself.
- Regarding effectiveness: in the relapsed/refractory AML subgroup treated with olutasidenib alone, there was an overall response rate of around forty-one percent, whereas, when combined with azacitidine, it increased slightly to forty-six percent. Among those who had not previously been treated (treatment-naive), these rates varied more significantly - a twenty-five percent response rate for monotherapy versus a seventy-seven percent when used in a combination therapy setting, showing promising results especially amongst the latter group.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Rezlidhia (olutasidenib) prescribing information. | 2022 | Rigel Pharmaceuticals, Inc. South San Francisco, CA |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Olutasidenib alone or with azacitidine in IDH1-mutated acute myeloid leukaemia and myelodysplastic syndrome: phase 1 results of a phase 1/2 trial. | 78Subjects F: 51% M: 49% | 2022 | The Lancet |
Sex Distribution:
F:51%
M:49%
78Subjects
Year:
2022
Source:The Lancet