Mikkael Sekeres, MD: Breakthrough Thereapy for Treating FLT3-ITD+ AML


Dr. Mikkael Sekeres discusses the approval of quizartinib (Vanflyta) and how it impacts the treatment of acute myeloid leukemia.

In an interview with HCPLive, Mikkael Sekeres, MD, chief, professor of medicine, Division of Hematology, Sylvester Cancer Center, Miami University, and chair of the committee of communications for the American Society of Hematology (ASH), discussed what the approval of quizartinib (Vanflyta) means for providers treating acute myeloid leukemia (AML).

“For a patient with a new diagnosis of acute myeloid leukemia, send a myeloid mutation panel and try to put a rush on it,” he said. “And as soon as those results come back, if a patient does have an FLT3-ITD mutation, then that patient should be started on a drug like quizartinib.”

The FLT3 inhibitor was granted approval by the FDA in combination with standard cytarabine and anthracycline induction, cytarabine consolidation, and as maintenance monotherapy for the treatment of adult patients with newly diagnosed AML with a positive FLT3-ITD mutation, as detected by an FDA-approved test.1

“This is particularly true among older adults, who have had much worse prognosis and may not eventually be eligible for a bone marrow transplant,” he explained. “We then continue a drug like quizartinib into the post-remission setting, but we don't add it to maintenance therapy following the transplant.”

Sekeres emphasized the agency stated the drug’s use as an initial treatment post-remission setting leading up to transplant, but not after transplant.

The supporting data from the phase 3 QuANTUM-First trial, showed that patients treated with quizartinib experienced a significant and clinically meaningful improvement in overall survival compared with those who received chemotherapy plus placebo.

The QuANTUM-First trial enrolled 539 patients with newly diagnosed, FLT3-ITD–positive AML, and they were randomly assigned to receive quizartinib or placebo in combination with induction and consolidation therapy, followed by maintenance monotherapy.

The median follow-up of the study was 39.2 months, and the median overall survival for patients treated with quizartinib was 31.9 months, while it was 15.1 months for patients who received placebo.

The complete response rate in both arms was 55%, with the median duration of response being 38.6 months in the quizartinib arm and 12.4 months in the control arm.

According to a statement from the developing company Daiichi-Sankyo, the approval of quizartinib represents a significant advancement for the treatment of patients with newly diagnosed FLT3-ITD–positive AML, as a particularly aggressive subtype that is difficult to treat.3


  1. Ryan C. FDA Approves Quizartinib Plus Chemotherapy for Newly Diagnosed, FLT3-ITD+ AML. OncLive. July 20, 2023. https://www.onclive.com/view/fda-approves-quizartinib-plus-chemotherapy-for-newly-diagnosed-flt3-itd-aml
  2. Vanflyta first FLT3 inhibitor approved in the US specifically for patients with newly diagnosed FLT3-ITD positive AML. News release. Daiichi Sankyo. July 20, 2023. Accessed July 20, 2023. https://www.daiichisankyo.com/files/news/pressrelease/pdf/202307/20230720_E.pdf
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