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| Molecular Profile | IDH1 R132C |
| Therapy | Olutasidenib |
| Indication/Tumor Type | acute myeloid leukemia |
| Response Type | sensitive |
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| IDH1 R132C | acute myeloid leukemia | sensitive | Olutasidenib | FDA approved - On Companion Diagnostic | Actionable | In a Phase II trial (Study 2102-HEM-101) that supported FDA approval, Rezlidhia (olutasidenib) treatment resulted in an objective response rate of 46% (57/123, 37 complete remission (CR), 4 CR with partial hematologic recovery, 14 CR with incomplete recovery, 1 morphologic leukemia-free state, 1 partial response) in patients with relapsed/refractory acute myeloid leukemia harboring a susceptible IDH1 mutation (R132C/G/H/L/S) (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 7006; NCT02719574). | detail... detail... detail... |
| IDH1 R132C | acute myeloid leukemia | sensitive | Olutasidenib | Case Reports/Case Series | Actionable | In a clinical case study, Rezlidhia (olutasidenib) treatment resulted in a complete response with treatment ongoing for at least 87 months in a patient with relapsed acute myeloid leukemia harboring IDH1 R132C, along with NPM1 W299Cfs*12 (PMID: 40594997). | 40594997 |
| PubMed Id | Reference Title | Details |
|---|---|---|
| Full reference... | ||
| Rezlidhia (olutasidenib) FDA Drug Label | Full reference... | |
| Effect of olutasidenib (FT-2102) on complete remissions in patients with relapsed/refractory (R/R) mIDH1 acute myeloid leukemia (AML): Results from a planned interim analysis of a phase 2 clinical trial. | Full reference... | |
| (40594997) | Functional cure with single agent olutasidenib in relapsed IDH1/NPM1 co-mutated AML. | Full reference... |