Priority Review Granted to Ivosidenib Tablets for IDH1-Mutated AML

By Sabrina Ahle - Last Updated: February 2, 2023

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.

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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.

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