Use of Vanflyta® Approved by FDA for Treating Adult Patients With AML, Acute Myeloid Leukemia
Daiichi Sankyo has announced that Vanflyta® (quizartinib) has been approved by the U.S. Food and Drug Administration. Vanflyta is an oral kinase inhibitor that may be used to treat adults with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive, in combination with standard treatments (cytarabine and anthracycline induction and cytarabine consolidation and maintenance). 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.
Up to 37% of newly diagnosed patients with AML have a FLT3 gene mutation and approximately 80% of these are FLT3-ITD mutations, which drive cancer growth and contribute to increased risk of relapse and shorter overall survival. The five-year survival rate for patients with FLT3-ITD AML has been reported at approximately 20%.
Do not take Vanflyta if you have very low potassium, very low magnesium, long QT syndrome, or a history of ventricular arrhythmias or torsades de pointes. Vanflyta may cause embryo-fetal toxicity. Females who can become pregnant should use effective birth control during treatment with Vanflyta and for 7 months after the last dose. Males with female partners who can become pregnant should use effective birth control during treatment and for 4 months after the last dose.
