fda alert

FDA Approves Two New Uses of Quizartinib for Acute Myeloid Leukemia

Leigh Precopio

The FDA approved two new uses for quizartinib in individuals with newly diagnosed acute myeloid leukemia (AML) that are FLT3 internal tandem duplication (ITD)-positive – quizartinib combined with standard cytarabine and anthracycline induction and cytarabine consolidation and as a maintenance monotherapy following consolidation chemotherapy.

This approval was based on a randomized, double-blind, placebo-controlled trial, which demonstrated that the quizartinib arm had a statistically significant improvement in overall survival from randomization date until death by any cause, when compared with the placebo arm (38.6 months vs 12.4 months, respectively). All patients were newly diagnosed FLT3-ITD positive AML, as identified by both a clinical trial assay and the LeukoStrat CDx FLT3 Mutation Assay, which was also recently approved as a companion diagnostic. 

For induction, the recommended dose of quizartinib is 35.4 mg orally once daily on days 8-21. Individuals should receive cytarabine on days 1 to 7 and daunorubicin or idarubicin on days 1 to 3. Patients are approved to receive up to two cycles of induction, with the second induction induction on a 7 + 3 or a 5 + 2 regimen.

For consolidation, 35.4 mg orally once daily is recommended on days 6-19 of high-dose cytarabine. Patients should receive high-dose cytarabine on days 1, 3, and 5, and are approved for up to four cycles.

For maintenance, 26.5 mg orally once daily is recommended for days 1 to 14. From there to day 28, 53 mg once daily is recommended. Patients can receive up to thirty-six 28-day cycles.

Adverse effects associated with quizartinib include QT prolongation, torsades de pointes, and cardiac arrest.

Quizartinib is currently only available under the Risk Evaluation and Mitigation Strategy restricted program. The treatment is not indicated for use as a maintenance monotherapy following allogeneic hematopoietic stem cell transplantation.



FDA approves quizartinib for newly diagnosed acute myeloid leukemia. News release. US Food and Drug Administration; July 20, 2023. Accessed October 10, 2023.