What is the role of ivosidenib in the treatment of acute myeloid leukemia (AML)?

Updated: May 26, 2020
  • Author: Karen Seiter, MD; Chief Editor: Emmanuel C Besa, MD  more...
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Answer

In May 2019, the FDA expanded use of ivosidenib for AML to include newly-diagnosed IDH1-mutated AML in adults aged 75 years or older, or adults who have comorbidities that preclude use of intensive induction chemotherapy. Approval was based on an open-label, single-arm, multicenter clinical trial (AG120-C-001, NCT02074839) that included 28 adult patients with newly-diagnosed AML with an IDH1 mutation. Efficacy was based on the rate of complete remission (CR) or complete remission with partial hematologic recovery (CRh), the duration of CR+CRh, and the conversion rate from transfusion dependence to transfusion independence. Twelve (42.9%) of the 28 achieved CR+CRh (95% CI: 24.5, 62.8), and 7 (41.2%) of the 17 transfusion-dependent patients achieved transfusion independence lasting at least 8 weeks. [73]


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