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Rebecca Olin, MD, MS

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FDA Brief: Ivosidenib for Acute Myeloid Leukemia Granted Priority Review

By: Lauren Velentzas
Posted: Friday, March 11, 2022

On March 7, Servier announced that the U.S. Food and Drug Administration (FDA) granted Priority Review to ivosidenib tablets in combination with azacitidine for previously untreated patients with IDH1-mutated AML. Approximately 10% of patients with AML harbor somatic mutations in IDH1. Ivosidenib is an oral inhibitor of IDH1 and is approved in the United States for treatment of adults with relapsed or refractory IDH1 mutation–positive AML or adults with newly diagnosed IDH1 mutation–positive AML who are 75 or older or ineligible for intensive induction chemotherapy due to comorbidities.

The Priority Review was granted based on the results of the randomized phase III AGILE trial. The global, double-blind trial included 146 patients with newly diagnosed, IDH1 mutation–-positive AML who were ineligible for induction chemotherapy. The results showed the addition of ivosidenib to azacitidine extended event-free survival (hazard ratio [HR] = 0.33; 95% confidence interval = 0.16–0.69) and overall survival (HR = 0.44; 95% CI = 0.27–0.73). All-grade adverse events occurred among at least 20% of patients assigned to receive ivosidenib.


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