The US Food and Drug Administration (FDA) has granted approval to Daiichi Sankyo’s Vanflyta (quizartinib) for newly diagnosed patients with FMS-like tyrosine kinase 3 receptor-internal tandem duplication (FLT3-ITD) positive acute myeloid leukemia (AML).
FLT3-ITD mutations occur in about a quarter of all AML cases.
Vanflyta is the first and only FLT3 inhibitor approved in the US for FLT3-ITD positive AML and across all three treatment phases: induction, consolidation and maintenance.
Vanflyta is approved to be used in combination with the current standard induction treatment of cytarabine and anthracycline, with cytarabine for consolidation and as a monotherapy for maintenance treatment.
AML is among the most common and aggressive forms of leukemia in adults and more than half of all patients relapse after initial treatment. In the US, an estimated 20,380 new cases are expected to be diagnosed this year, outlined Daiichi in a press release.
Up to 37 percent of newly diagnosed AML patients have a mutation in the FLT3 gene and of these, 80 percent are FLT3-ITD mutations. The mutation is thought to drive cancer growth, promote an increased risk of relapse and is associated with shorter overall survival. The five-year survival rate of patients with FLT3-ITD positive AML is 20 percent, according to Daiichi. The five-year survival for all AML is estimated to be only slightly higher at around 30 percent and makes up two percent of all cancer deaths in the US.
Vanflyta is a small molecule inhibitor that specifically targets ITD mutations in the FLT3 receptor.
Despite the advent of targeted therapies, conventional AML treatment has remained largely the same for over four decades, consisting of intensive induction chemotherapy followed by consolidation therapy that can include hematopoietic stem cell transplantation (HSCT) for eligible patients. For some patients that achieve remission, post-consolidation/maintenance therapy can be recommended.
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Efficacy and Safety of Vanflyta
Vanflyta’s FDA approval was based on results of the QuANTUM-First trial published in The Lancet. Results from the trial showed that in patients with newly diagnosed FLT3-ITD positive AML, Vanflyta in combination with standard cytarabine and anthracycline induction, standard cytarabine consolidation and continued as maintenance monotherapy, cut the risk of death by 22 percent compared to standard chemotherapy alone.
Although complete remission (CR) rates were similar between both groups, the median duration of CR was more than three times longer at 38.6 months for patients receiving Vanflyta compared to 12.4 months for those receiving placebo plus standard chemotherapy alone, according to data shared by Daiichi.
Quizartinib was approved in Japan in 2019 and faced a US rejection that same year, one of several on its road to FDA approval. Back then, an FDA advisory committee expressed concerns over the reliability of the company’s presented Phase III data. Last June, Daiichi shared positive Phase III survival data that put it in a position for regulatory filings across different countries including the US.
This year, the agency delayed its decision on the therapy from April to July to review proposed updates to Daiichi’s safety monitoring program.
Vanflyta carries a boxed warning for heart risks including QT prolongation, which is an extended interval between the heart contracting and relaxing. As such, Vanflyta will only be available under certain conditions through the Vanflyta Risk Evaluation and Mitigation Strategy.
Price of Vanflyta and Market Competition
Daiichi revealed that the wholesale acquisition cost of Vanflyta is $546 per tablet for both the 17.7 mg and 26.5 mg dose.
While Vanflyta has the advantage of being the first and only FLT3-ITD-specific inhibitor and the only approved FLT3 inhibitor across all AML treatment phases, it will still be facing competition from other FLT3 inhibitors, namely Novartis’ Rydapt (midostaurin) and Astellas’ Xospata (gilteritinib). The drugs target other, non-ITD mutations in the FLT3 receptor.
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