FDA Approves Quizartinib Plus Chemotherapy for Newly Diagnosed FLT3-ITD AML

Quizartinib (VANFLYTA) has been approved by the US Food and Drug Administration (FDA) in combination with cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy.

The approval is for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) who have FLT3-ITD as detected by an FDA-approved test, according to a news release from Daiichi Sankyo, the manufacturer of the drug.

Quizartinib is the “first and only FLT3 inhibitor to be approved by the FDA specifically for FLT3-ITD positive AML and across the three phases of treatment—induction, consolidation and maintenance in patients without transplant—for newly diagnosed AML,” according to the release.

The FDA approval of quizartinib is based upon results from the QuANTUM-First trial, which were published in The Lancet. The trial included patients who had newly diagnosed FLT3-ITD AML. It showed a 22% reduction in the risk of death compared to standard chemotherapy alone in patients who received quizartinib plus standard cytarabine and anthracycline induction, standard cytarabine consolidation, and continued maintenance monotherapy following consolidation. Investigators evaluated the safety of quizartinib in 265 patients who received it once daily in the trial.

The NCRI AML18 trial also evaluated the sequential addition of quizartinib to intensive chemotherapy in older adults with AML.

Quizartinib is approved with a Boxed Warning for QT prolongation, torsades de pointes, and cardiac arrest. Due to the “serious risk” of QT prolongation, torsades de pointes, and cardiac arrest, quizartinib will be available only through a restricted program called the VANFLYTA Risk Evaluation and Mitigation Strategy, according to the news release. The drug will be available by prescription in the coming weeks, officials said.

Source: BusinessWire, July 2023