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Indications of Ivosidenib

Ivosidenib is indicated for patients whose susceptible isocitrate dehydrogenase-1 (IDH1) mutation has been detected using an FDA-approved test. The specific indications are as follows:

1. Newly Diagnosed Acute Myeloid Leukemia (AML)

In combination with azacitidine, or as monotherapy, for adult patients aged ≥75 years with newly diagnosed AML, or for adult patients with newly diagnosed AML who have comorbidities that preclude the use of intensive induction chemotherapy.

2. Relapsed or Refractory Acute Myeloid Leukemia (AML)

For the treatment of adult patients with relapsed or refractory AML.

3. Relapsed or Refractory Myelodysplastic Syndromes (MDS)

For the treatment of adult patients with relapsed or refractory myelodysplastic syndromes.

4. Locally Advanced or Metastatic Cholangiocarcinoma

For the treatment of adult patients with previously treated locally advanced or metastatic cholangiocarcinoma.

from FDA，2023.10