This site is intended for healthcare professionals

FDA approves ivosidenib + azacitidine for newly diagnosed IDH1-mutated AML.

Read time: 1 mins
Published:30th May 2022

The FDA has approved ivosidenib (Tibsovo) in combination with azacitidine for the treatment of patients with newly diagnosed IDH1-mutated acute myeloid leukemia (AML) who are aged 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

The expanded approval is supported by findings from the phase III AGILE trial, which showed that ivosidenib plus azacitidine significantly improved event-free survival (EFS) over azacitidine alone (HR, 0.35; 95% CI, 0.17-0.72; 2-sided P = .0038).2 The addition of ivosidenib also improved median overall survival (OS) compared with azacitidine alone, at 24.0 months (95% CI, 11.3-34.1) vs 7.9 months (95% CI, 4.1-11.3), respectively (HR, 0.44; 95% CI, 0.27-0.73; P = .001).

See- Montesinos P, Recher C, Vives S, et al. "Ivosidenib and azacitidine in IDH1-mutated acute myeloid leukemia". N Engl J Med. 2022;386(16):1519-1531. doi:10.1056/NEJMoa2117344.

Condition: Acute Myeloid Leukemia (AML)
Type: drug

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.