Can Vanflyta be used to treat newly diagnosed FLT3-ITD-Positive Acute Myeloid Leukemia in adults?

Vanflyta (quizartinib) is a targeted therapy for adults with newly diagnosed acute myeloid leukemia (AML) that has a specific mutation called FLT3-ITD. The U.S. Food and Drug Administration (FDA) has approved Vanflyta for this exact use. It is given together with standard chemotherapy (induction and consolidation) and then as a maintenance treatment afterward. However, it is not approved for use as maintenance therapy after a stem cell transplant.

What the research says

The FDA approval of Vanflyta for newly diagnosed FLT3-ITD-positive AML is based on the phase 3 QuANTUM-First trial ⁷⁹. In this trial, patients received either quizartinib or a placebo along with standard chemotherapy, followed by maintenance therapy. Results showed that quizartinib improved overall survival compared to placebo ⁹¹⁰. A network meta-analysis also found that quizartinib significantly prolonged overall survival in AML patients (HR=0.73, 95% CI: 0.54-0.98) ¹. The QuANTUM-First trial further analyzed the role of stem cell transplant: among patients who achieved remission, those who received quizartinib and later underwent a stem cell transplant had better survival outcomes ⁹. However, Vanflyta is not indicated as maintenance therapy after allogeneic stem cell transplant because improved survival in that setting has not been demonstrated ⁷. Vanflyta is a potent and selective FLT3 inhibitor, meaning it specifically targets the FLT3-ITD mutation ¹⁰.

What to ask your doctor

• Is Vanflyta (quizartinib) an option for my newly diagnosed FLT3-ITD-positive AML?
• What are the potential side effects of Vanflyta when combined with chemotherapy?
• How does Vanflyta compare to other FLT3 inhibitors like midostaurin or gilteritinib for my situation?
• If I am a candidate for a stem cell transplant, how does Vanflyta fit into my treatment plan?
• What monitoring or tests are needed while taking Vanflyta?