Indications of Ivosidenib

1.Newly Diagnosed Acute Myeloid Leukemia

Ivosidenib is indicated in combination with azacitidine or as monotherapy for the treatment of  newly diagnosed acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1  (IDH1) mutation as detected by an FDA-approved test in adults 75 years or older, or who have  comorbidities that preclude use of intensive induction chemotherapy.

2.Relapsed or Refractory Acute Myeloid Leukemia

Ivosidenib is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as  detected by an FDA-approved test.

3.Relapsed or Refractory Myelodysplastic Syndromes

Ivosidenib is indicated for the treatment of adult patients with relapsed or refractory  myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1)  mutation as detected by an FDA-approved test.

4.Locally Advanced or Metastatic Cholangiocarcinoma

Ivosidenib is indicated for the treatment of adult patients with previously treated, locally  advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation  as detected by an FDA-approved test.

from FDA，2023.10