Medication Monitor

Generic Name (Trade Name—Company)
June 11, 2019


Ivosidenib now approved for treatment of newly diagnosed AML

FDA approved a new indication for ivosidenib, an isocitrate dehydrogenase-1 (IDH1) inhibitor, to treat adults with newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. Patients must be aged 75 years or older and have comorbidities that preclude use of intensive induction chemotherapy.

The agent received initial FDA approval in July 2018 for adult patients with relapsed or refractory (R/R) AML and an IDH1 mutation.