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A non-purine selective inhibitor of xanthine oxidase (XO) in prevention of Tumour Lysis Syndrome (TLS)

Present development stage: Pediatric Clinical Phase I/II

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”. Currently, the clinical phase I/II FLORET is ongoing for the same indication in the paediatric population.

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