Vanflyta FDA Approval History
Last updated by Judith Stewart, BPharm on July 20, 2023.
FDA Approved: Yes (First approved July 20, 2023)
Brand name: Vanflyta
Generic name: quizartinib
Dosage form: Tablets
Company: Daiichi Sankyo Inc.
Treatment for: Acute Myeloid Leukemia
Vanflyta (quizartinib) is an oral FLT3-ITD (FMS-like tyrosine kinase-3-internal tandem duplication) inhibitor for the treatment of patients with FLT3-ITD positive acute myeloid leukemia.
- Vanflyta is indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test.
Vanflyta is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with Vanflyta in this setting has not been demonstrated. - Acute myeloid leukemia (AML) is a cancer that affects the blood and bone marrow. A number of gene mutations have been identified in AML, with FLT3 mutations being the most common. Approximately 80% of FLT3 mutations in AML are FLT3-ITD (internal tandem duplications) and these patients typically have a poor prognosis with an increased risk of relapse and a shorter overall survival.
- Vanflyta contains quizartinib, which is a highly potent type II FLT3 inhibitor that selectively targets FLT3-ITD mutations. It was specifically developed for patients with FLT3-ITD positive AML.
- Approval for Vanflyta was based on the results from the QuANTUM-First trial, which demonstrated that quizartinib combined with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and continued as monotherapy following consolidation, resulted in a statistically significant and clinically meaningful improvement in overall survival in adult patients with newly diagnosed FLT3-ITD positive AML compared to chemotherapy alone.
- Vanflyta tablets are taken orally once daily with or without food, at approximately the same time each day.
- The Vanflyta product label carries a Boxed Warning for QT interval prolongation, torsades de pointes, and cardiac arrest. Vanflyta is available only through a restricted program called the Vanflyta Risk Evaluation and Mitigation Strategy (REMS).
- Warnings and precautions associated with Vanflyta include QT prolongation, torsades de pointes, and cardiac arrest. Patients should have electrocardiograms and levels of serum electrolytes monitored. Vanflyta treatment should be reduced, interrupted, or permanently discontinued as appropriate. Vanflyta may also cause fetal harm.
- Common adverse reactions include diarrhea, mucositis, nausea, calcium decreased, abdominal pain, sepsis, neutropenia, headache, vomiting, and upper respiratory tract infection.
Common laboratory abnormalities include decreased lymphocytes, decreased potassium, decreased albumin, decreased phosphorus, increased alkaline phosphatase, decreased magnesium, febrile neutropenia, and increased creatine phosphokinase.
Development timeline for Vanflyta
Further information
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