Febuxostat (Adenuric®) is a potent, non-purine selective inhibitor of xanthine oxidase (XO), approved in EU through a centralized procedure in April 2008 with the following indication: “treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including history, or presence of tophus and/or gouty arthritis)”.
After completing the development in adults as preventive treatment of the Tumour Lysis Syndrome, in 2015 Febuxostat obtained the approval in Europe for the “prevention/treatment of the Tumour Lysis Syndrome in adult patients with haematological neoplasia treated with chemotherapy”.
In order to verify the efficacy in comparison to the current standard therapy of allopurinol, the phase III study FLORENCE has been conducted enrolling 347 patients with lymphoma and leukemia, in 79 highly specialized centers for the treatment of haematological tumours.
Febuxostat, compared to the standard of care, has shown in adult patients a significant superiority in the control of uricaemia in intermediate/high risk patients with tumor lysis syndrome.
Currently the fase I/II study FLORET is ongoing in the pediatric population for the same indication.
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