What is ivonib/ivitinib and what are its indications?

Ivosidenib/Ivosidenib is an isocitrate dehydrogenase-1 (IDH1) inhibitor, used to treat patients with IDH1-mutated acute myeloid leukemia (AML), IDH1-mutated cholangiocarcinoma, and IDH1-mutated myelodysplastic syndromes. Ivonib is indicated for the treatment of adult patients with predisposing IDH1 mutations detected by FDA-approved tests, including:

1. Acute myeloid leukemia (AML):

(1) Newly Diagnosed AML: Indicated for use in combination with azacitidine or as monotherapy for newly diagnosed acute myeloid leukemia with a predisposing isocitrate dehydrogenase-1 (IDH1) mutation detected by an FDA-approved test in adults 75 years of age or older or who have comorbidities that preclude the use of intensive induction chemotherapy.

(2) Relapsed or refractory (R/R) AML: Indicated for the treatment of adult patients with R/R AML who have a susceptibility isocitrate dehydrogenase-1 (IDH1) mutation detected by an FDA-approved test.

2. Relapsed or refractory (R/R) myelodysplastic syndrome (MDS): It is suitable for the treatment of adult patients with R/R MDS who have susceptibility to isocitrate dehydrogenase-1 (IDH1) mutations detected by FDA-approved tests.

3. Locally advanced or metastatic cholangiocarcinoma: It is suitable for the treatment of adult patients with previously treated locally advanced or metastatic cholangiocarcinoma who have isocitrate dehydrogenase-1 (IDH1) mutations detected by an FDA-approved test.

Ivonib is an isocitrate dehydrogenase-1 inhibitor that works by reducing the abnormal production of the tumor metabolite 2-hydroxyglutarate (2-HG), which leads to the differentiation of malignant cells. Patients are required to take ivonib tablets by mouth once daily, with or without food, until disease progression or unacceptable toxicity occurs.