Mikkael Sekeres, MD: FDA Approves Quizartinib for FLT3-ITD Positive AML

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This approval is the first for an FLT3 inhibitor and it's specifically indicated for patients who have FLT3-ITD.

Quizartinib (Vanflyta) was approved by the US Food and Drug Administration (FDA) for the treatment of newly diagnosed acute myeloid leukemia (AML) patients with a specific genetic mutation called FLT3-ITD positive AML. The approval was based on the results of the QuANTUM-First trial.1

“For the first time, we have the FDA approval of an FLT3 inhibitor that was studied in older adults–recall that midostaurin was studied in patients up to the age of 60–and then we cross-applied it to patients who were older,” Mikkael Sekeres, MD, chief, professor of medicine, Division of Hematology, Sylvester Cancer Center, Miami University, chair of the committee of communications, American Society of Hematology (ASH), said in an interview with HCPLive.

“Secondly, we have a drug that is specifically approved for patients who have the worst FLT3 mutation, the ITD mutation.”

In the randomized clinical trial, quizartinib was combined with standard cytarabine and anthracycline induction therapy, followed by standard cytarabine consolidation. After consolidation, quizartinib was continued as maintenance monotherapy.

“People who have acute myeloid leukemia are risk-stratified after diagnosis,” Sekeres said. “Some of those risks are clinical, for example, if a person is older or younger, older adults with acute myeloid leukemia have worse outcomes than those with younger adults.”

The trial data demonstrated that the addition of quizartinib to standard chemotherapy significantly improved overall survival and prolonged the duration of complete remission in patients with newly diagnosed FLT3-ITD positive AML compared with standard chemotherapy alone.

“This trial was interesting in that it enrolled patients who were younger and older, so patients could enter this study if they were as old as 75 years,” Sekeres explained.


  1. Ryan C. FDA Approves Quizartinib Plus Chemotherapy for Newly Diagnosed, FLT3-ITD+ AML. OncLive. July 20, 2023.