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