The approval was based on the findings from the QuANTUM-First trial in which the Vanflyta combination showed a 22% reduction in the risk of death compared to standard chemotherapy alone
Daiichi Sankyo gets EC approval for Vanflyta in FLT3-ITD positive AML. (Credit: DAIICHI SANKYO COMPANY, LIMITED)
Daiichi Sankyo’s Vanflyta (quizartinib) has received approval from the European Commission (EC) for adult patients in the European Union (EU) with newly diagnosed FLT3-ITD positive acute myeloid leukaemia (AML).
Designed to selectively target FLT3-ITD mutations, Vanflyta is an oral, highly potent type 2 FLT3 inhibitor.
The Commission has granted approval for the FLT3 inhibitor to be utilised in combination with standard cytarabine and anthracycline induction, along with standard cytarabine consolidation chemotherapy. This is followed by Vanflyta single-agent maintenance treatment.
Daiichi Sankyo president and CEO and oncology business global head Ken Keller said: “With the approval of Vanflyta in the European Union, patients diagnosed with FLT3-ITD positive acute myeloid leukemia may for the first time receive a targeted therapy developed and approved specifically for their disease subtype.
“Vanflyta is the second innovative medicine from our oncology pipeline approved in the EU and its successful development reflects our commitment to creating new standards of care for patients with cancer.”
The drug’s approval comes after the positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
It was based on the findings of the QuANTUM-First trial in which the Vanflyta combination showed a 22% reduction in the risk of death compared to standard chemotherapy alone.
QuANTUM-First is a randomised, double-blind, placebo-controlled, global Phase 3 trial of 539 adult patients of age between 18 and 75 with newly diagnosed FLT3-ITD positive AML.
The primary study endpoint of the trial was defined as the overall survival and key secondary endpoints included postinduction rates of complete remission (CR), event-free survival, and composite complete remission (CRc), and others.
The median overall survival was observed at 31.9 months for patients receiving Vanflyta compared to 15.1 months for patients in the control arm at a median follow-up of 39.2 months.
Additionally, the safety profile of the FLT3 inhibitor in QuANTUM-First was consistent with previous clinical studies with no record of new safety signals.
The drug is approved in the US for similar indication for patients detected with a US Food and Drug Administration (FDA)-approved test.