Tibsovo Now Indicated for First-Line Treatment of Patients with AML and IDH1 Mutation

June 2019, Vol 10, No 3

On May 2, 2019, the FDA approved ivosidenib (Tibsovo; Agios) for patients with newly diagnosed acute myeloid leukemia (AML) and a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients aged ≥75 years or those who have comorbidities that preclude the use of intensive induction chemotherapy. Ivosidenib was originally approved in 2018 for relapsed or refractory AML with IDH1 mutation.

The new indication was based on an open-label, single-arm, multicenter clinical trial using ivosidenib monotherapy for patients with newly diagnosed AML and an IDH1 mutation, which was detected by the Abbott RealTime™ IDH1 Assay. All patients were aged ≥75 years or had comorbidities that precluded the use of intensive chemotherapy.

The efficacy was determined based on complete remission (CR) rate or complete remission with partial hematologic recovery (CRh), the duration of CR + CRh, and the conversion from transfusion-dependence to transfusion independence. In total, 12 (42.9%) of 28 patients achieved CR + CRh, and 7 (41.2%) of the 17 transfusion-dependent patients achieved transfusion independence lasting ≥8 weeks.

The most common (≥25%) adverse reactions were diarrhea, fatigue, edema, decreased appetite, leukocytosis, nausea, arthralgia, abdominal pain, dyspnea, differentiation syndrome, and myalgia.

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