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On May 10, 2023, oral ivosidenib, a small molecular isocitrate dehydrogenase-1 (IDH1) inhibitor, was approved by the European commission in combination with azacitidine for the treatment of adult patients with newly diagnosed (ND) acute myeloid leukemia (AML) with an IDH1R132 mutation who are ineligible for standard induction chemotherapy.1
Following key data from the phase III AGILE trial (NCT03173248), ivosidenib in combination with azacitidine is already approved by the U.S Food and Drug Administration (FDA) for the treatment of IDH1-mutated AML in adult patients ≥75 years old and for those with comorbidities precluding the use of standard intensive induction chemotherapy.2 Results demonstrated a favorable safety profile, improved event-free survival (hazard ratio [HR], 0.33; 95% confidence interval [CI], 0.16, 0.69), and improved overall survival (HR, 0.44; 95% CI, 0.27, 0.73) in patients with IDH1-mutated ND AML who received ivosidenib plus azacitidine, compared with those who received azacitidine plus placebo.1
Ivosidenib is also FDA approved as a monotherapy in patients with relapsed/refractory or ND IDH1-mutated AML3, and in patients with locally advanced or metastatic IDH1-mutated cholangiocarcinoma who have been previous treated.1,3
Ivosidenib in combination with azacitidine receives FDA approval for the treatment of IDH1-mutated newly diagnosed AML
On May 25, 2022, it was announced that the U.S. Food and Drug Administration (FDA) approved the use of ivosidenib tablets in...
Visual abstract | AGILE study of ivosidenib + azacitidine versus placebo + azacitidine in newly diagnosed patients with an IDH1 mutation
The AML Hub is happy to present a Visual Abstract representing key data from the phase III AGILE study,...
Ivosidenib approved as first-line treatment for AML with IDH1 mutation
Ivosidenib has been granted approval by the U.S. FDA as first-line treatment for newly diagnosed AML with IDH1 mutation.
FDA grants ivosidenib priority review for the treatment of patients with newly diagnosed IDH1-mutant acute myeloid leukemia
The FDA have granted ivosidenib a supplemental new drug application (sNDA) the treatment of patients with newly diagnosed...
FDA grants Tibsovo (ivosidenib) approval for the treatment of patients with relapsed/refractory acute myeloid leukemia with IDH1 mutation
The FDA has granted approval to Tibsovo (ivosidenib) for the treatment of adult patients with R/R AML with an...
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