The FDA approval was based on the data from the QuANTUM-First trial in which the Vanflyta combination reduced the risk of death by 22% in comparison to standard chemotherapy alone
Daiichi Sankyo Stone Monument in Japan. (Credit: DAIICHI SANKYO COMPANY, LIMITED)
Japanese pharmaceutical company Daiichi Sankyo has received approval from the US Food and Drug Administration (FDA) for Vanflyta (quizartinib) to treat adult patients with newly diagnosed acute myeloid leukaemia (AML) that is FLT3-ITD positive as detected by an FDA-approved test.
FDA has approved Vanflyta in combination with standard cytarabine and anthracycline induction and cytarabine consolidation and as maintenance monotherapy post-consolidation chemotherapy.
Developed specifically for patients with FLT3-ITD positive AML, Vanflyta is an oral, type 2 FLT3 inhibitor that selectively targets FLT3-ITD mutations.
The FDA approval was based on the data from the QuANTUM-First trial.
In the study, the Vanflyta combination reduced the risk of death by 22% in comparison to standard chemotherapy alone.
While complete remission (CR) rates were comparable in both trial arms, patients receiving Vanflyta experienced complete remissions on average for 38.6 months as opposed to 12.4 months for patients receiving placebo plus standard chemotherapy alone.
Daiichi Sankyo president and CEO and Oncology Business global head Ken Keller said: “Today’s FDA approval of Vanflyta is an important milestone, as patients with the FLT3-ITD subtype of AML can now be treated with the first-ever FLT3 inhibitor approved across the three phases of treatment these patients typically receive.
“Vanflyta represents the third oncology medicine from Daiichi Sankyo to be approved in the US and reflects our commitment to continuously deliver innovative medicines that improve the current standard of care.”
QuANTUM-First is a randomised, double-blind, placebo-controlled global Phase 3 study.
It randomised 265 adult patients aged 18-75 with newly diagnosed FLT3-ITD positive AML 1:1 to receive VANFLYTA or placebo combined with cytarabine and anthracycline induction and cytarabine consolidation chemotherapy followed by up to three years of single-agent maintenance.
The primary endpoint of QuANTUM-First was defined as overall survival, the pharmaceutical company said.
The secondary endpoints included event-free survival, post-induction rates of CR and composite complete remission (CRc), and the percentage of patients who met CR or CRc with FLT3-ITD measurable residual disease negativity.