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News of Ivosidenib

On July 20, 2018, the U.S. Food and Drug Administration (FDA) approved ivosidenib for the treatment of relapsed or refractory acute myeloid leukemia (AML) with an IDH1 mutation.

On May 2, 2019, Agios Pharmaceuticals announced that the FDA had approved ivosidenib as a monotherapy for adult patients with newly diagnosed IDH1-mutated AML who are ineligible for intensive chemotherapy.

On August 25, 2021, Servier announced that the FDA had approved ivosidenib for the treatment of IDH1-mutated cholangiocarcinoma.

On May 25, 2022, Servier announced that the FDA had approved ivosidenib in combination with azacitidine for the treatment of patients with newly diagnosed IDH1-mutated acute myeloid leukemia.

On October 24, 2023, Servier announced that the U.S. Food and Drug Administration (FDA) had approved ivosidenib for the treatment of relapsed or refractory myelodysplastic syndromes (MDS) with isocitrate dehydrogenase 1 (IDH1) mutations.

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