Ivosidenib & Acute myeloid leukemia (AML) (IDH1 m)

Approval status

Ivosidenib is FDA approved as monotherapy for adults with relapsed or refractory Acute myeloid leukemia (AML) (IDH1 m), detected by an FDA-approved test. In 2019, the FDA expanded the indication to include newly diagnosed IDH1-mutated AML in adults aged 75 or older, or those with comorbidities that preclude intensive induction chemotherapy, also as monotherapy (2, 3
Ivosidenib is EMA approved only in combination with azacitidine for adult patients with newly diagnosed AML with an IDH1 R132 mutation who are not eligible for standard induction chemotherapy.

Clinical data

The clinical phase I trial showed that in patients with adva…