Drug updated on 10/24/2024
| Dosage Form | Capsule (oral; 150 mg) |
| Drug Class | Isocitrate dehydrogenase-1 (IDH1) 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.
Latest News
Summary
- This summary is based on the review of two randomized controlled trial(s). [1-2]
- In relapsed/refractory AML, monotherapy with Olutasidenib resulted in an overall response of 41% (95% Confidence Interval (CI) 21-64), while combination therapy with Azacitidine led to a higher overall response of 46% (95% CI 27-67). Among treatment-naive AML patients, overall response rates were 25% (95% CI 1-81) with monotherapy and 77% (95% CI 46-95) with combination therapy.
- In relapsed/refractory gliomas with the IDH1R132X mutation, Olutasidenib monotherapy demonstrated a disease control rate of 48%, including an 8% partial response rate (2 patients) and 32% (8 patients) achieving stable disease for at least 4 months.
- AML and MDS: Common Grade 3-4 treatment-emergent adverse events for monotherapy included thrombocytopenia (28%), febrile neutropenia (22%), and anemia (22%). For combination therapy, thrombocytopenia (41%), febrile neutropenia (28%), neutropenia (28%), and anemia (20%) were reported. Mortality rates were 34% in monotherapy and 20% in combination therapy, primarily due to disease progression, with no deaths considered study-drug related.
- Relapsed/Refractory Gliomas: Common Grade 3-4 adverse events included increased alanine aminotransferase (12%) and increased aspartate aminotransferase (12%). No dose-limiting toxicities were observed.
- There is no population types or subgroups information available in the reviewed documents.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Rezlidhia (olutasidenib) Prescribing Information. | 2024 | 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% | 2023 | The Lancet |
| Olutasidenib (FT-2102) in patients with relapsed or refractory IDH1-mutant glioma: A multicenter, open-label, phase Ib/II trial | 26Subjects F: 35% M: 65% | 2023 | Neuro-oncology |
Sex Distribution:
F:51%
M:49%
78Subjects
Year:
2023
Source:The Lancet
Sex Distribution:
F:35%
M:65%
26Subjects
Year:
2023
Source:Neuro-oncology