FDA Approves Vanflyta Regimen for AML Subset

The Food and Drug Administration (FDA) approved Vanflyta (quizartinib) plus cytarabine and anthracycline induction and cytarabine consolidation, as a maintenance therapy after consolidation chemotherapy for the treatment of adults with newly diagnosed, FLT3 internal tandem duplication (ITD)-positive acute myeloid leukemia (AML), according to the FDA.

The agency also approved the LeukoStrat CDx FLT3 Mutation assay as a companion diagnostic to determine which patients are eligible for this therapy.

The approval is based off findings from the QuANTUM-First clinical trial, which included 539 patients with newly diagnosed, FLT-ITD—positive AML, as determined by the LeukoStrat CDx FLT3. A total of 268 patients were randomly assigned to receive Vanflyta, while 271 were randomly assigned to receive a placebo with induction (initial therapy) and then again as maintenance therapy (given to prevent the cancer from coming back).

The main goal of the trial was to determine if Vanflyta improved overall survival, which is a statistic that outlines time from the time the patients were randomized to their respective groups until they died of any cause. Study findings showed that patients given Vanflyta tended to have improved survival than those in the placebo group.

In both groups, 55% of patients experienced a complete response, meaning that there were no signs of cancer after treatment. However, the average duration of response was longer in the Vanflyta group (38.6 months) than in the placebo group (12.4 months).

Of note, Vanflyta is not approved as a maintenance monotherapy following allogeneic hematopoietic stem cell transplant, and no improvement in overall survival has been observed in this setting, according to the FDA.

Additionally, Vanflyta comes with a boxed warning, which outlines potential risks of a drug, regarding QT prolongation (extended intervals between the heart contracting and relaxing), torsades de pointes (fast heartbeat) and cardiac arrest.

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