Priority Review Granted to Ivosidenib Tablets for IDH1-Mutated AML

The US Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for ivosidenib tablets as a proposed treatment for patients with previously untreated IDH1-mutated acute myeloid leukemia (AML). Additionally, the sNDA received priority review status.

Acceptance of the sNDA is based on results from the phase III AGILE study demonstrating that treatment with ivosidenib tablets plus azacitidine significantly improved event-free survival and overall survival in this population.

Currently, ivosidenib tablets are approved as monotherapy for adults with IDH1-mutant relapsed or refractory AML, adults with newly diagnosed IDH1-mutant AML older than 75 years old or with comorbidities that preclude the use of intensive induction chemotherapy, and patients with previously treated IDH1-mutated cholangiocarcinoma.

Source: Servier press release, March 7, 2022.