Daiichi Sankyo’s Vanflyta (quizartinib) has been recommended by the National Institute for Health and Care Excellence (NICE) for certain cases of acute myeloid leukaemia (AML).
The drug has been specifically recommended for routine NHS commissioning in England and Wales as an induction, consolidation and maintenance therapy for newly diagnosed FLT3-ITD-positive disease.
Approximately 18,000 people are diagnosed with AML, a type of blood cancer that starts from young white blood cells in the bone marrow, every year in Europe.
FLT3-ITD mutations occur in up to 30% of all AML cases and are associated with an increased risk of relapse and shorter overall survival.
Vanflyta, taken orally once daily, is the first selective FLT3 inhibitor to be approved in the UK for newly diagnosed FLT3-ITD-positive AML.
NICE’s decision on the drug follows an approval from the Medicines and Healthcare products Regulatory Agency in March and was supported by positive results from the late-stage QuANTUM-First trial.
Results from the study showed that Vanflyta in combination with standard induction and consolidation chemotherapy, and then continued as a maintenance monotherapy, demonstrated a 22% reduction in the risk of death compared to standard chemotherapy alone.
Median overall survival was 31.9 months for patients receiving Vanflyta versus 15.1 months for those in the control arm at a median follow-up of 39.2 months.
Commenting on the recommendation, Haran Maheson, head of UK oncology and vice president, Daiichi Sankyo UK, said: “We are proud to have worked with NICE and NHS England to secure the first reimbursement for [Vanflyta] following health technology assessment in Europe.
“UK patients with newly diagnosed FLT3-ITD positive AML can now receive a selective targeted therapy for their disease for the first time.”
Sharing a similar sentiment, Colin Dyer, chief executive of UK charity Leukaemia Care, said: “We welcome the decision by NICE to approve this treatment… Patients with FLT3-ITD mutations have an increased risk of relapse with standard treatments, so another targeted treatment option for such patients is important for clinicians to tailor treatment plans to their patients effectively.”