NICE Recommends Vanflyta for Acute Myeloid Leukemia

Daiichi Sankyo’s Vanflyta (quizartinib) has received a recommendation from the National Institute for Health and Care Excellence (NICE) for use in certain cases of acute myeloid leukaemia (AML). The drug is specifically recommended for routine NHS commissioning in England and Wales as an induction, consolidation, and maintenance therapy for patients newly diagnosed with FLT3-ITD-positive AML.

In Europe, approximately 18,000 individuals are diagnosed with AML each year. AML is a form of blood cancer that originates from immature white blood cells in the bone marrow. Among these cases, FLT3-ITD mutations occur in up to 30% and are linked to a higher likelihood of relapse and reduced overall survival rates.

Vanflyta, an orally administered medication taken once daily, is notable for being the first selective FLT3 inhibitor approved in the UK for patients newly diagnosed with FLT3-ITD-positive AML. This recent endorsement by NICE follows an earlier approval by the Medicines and Healthcare products Regulatory Agency in March, which was based on promising outcomes from the late-stage QuANTUM-First trial.

The QuANTUM-First trial demonstrated that when Vanflyta was used in combination with standard induction and consolidation chemotherapy, followed by maintenance monotherapy, there was a 22% reduction in the risk of death compared to standard chemotherapy alone. The study revealed that the median overall survival for patients treated with Vanflyta was 31.9 months, significantly higher than the 15.1 months observed in the control group, at a median follow-up of 39.2 months.

Haran Maheson, head of UK oncology and vice president at Daiichi Sankyo UK, expressed pride in collaborating with NICE and NHS England to achieve the first reimbursement for Vanflyta following a health technology assessment in Europe. He stated, "UK patients with newly diagnosed FLT3-ITD positive AML can now receive a selective targeted therapy for their disease for the first time."

Colin Dyer, chief executive of the UK charity Leukaemia Care, echoed this sentiment, welcoming NICE's decision. He highlighted the importance of having another targeted treatment option, noting that patients with FLT3-ITD mutations face an increased risk of relapse with standard treatments. Dyer emphasized that such targeted therapies allow clinicians to tailor treatment plans more effectively to individual patient needs.