New Sanofi-Synthelabo cancer drug OKed in EU

29 March 2001

Sanofi-Synthelabo has been granted centralized marketing approval in theEuropean Union for a recombinant urate oxidase product, Fasburtec (rasburicase), which is used to reduce levels of uric acid in patients with cancer. Specifically, the drug is indicated for the treatment and prophylaxis of acute hyperuricemia in order to prevent renal failure in patients with hematological malignancy with a high tumor burden who are at risk of rapid tumor lysis or shrinkage at initiation of chemotherapy.

Rapid increases in uric acid plasma levels are often seen when chemotherapy is initiated for hematological cancers, especially in children, and can lead to precipitation of uric acid in the kidneys and renal failure. This can be life-threatening and often requires treatment with dialysis. Administration of Fasburtec converts uric acid into allantoin, which is much more soluble and can be excreted by the kidneys.

The first launches of Fasburtec are expected to take place in the second quarter of this year, according to Sanofi-Synthelabo, which notes that it expects worldwide sales of the product to reach 100 million euros ($90 million) in 2005.

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