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FDA Approves Elitek(R) (rasburicase) for Management of Plasma Uric Acid Levels in Adults with Leukemia, Lymphoma, and Solid Tumors Receiving Anti-Cancer Therapy
Date:10/16/2009

fits to pediatric patients at risk of developing this complication - has now been approved by the U.S. Food and Drug Administration to help adult patients as well," said Dr. Paul Chew, Senior Vice President, U.S. Chief Science Officer/Chief Medical Officer of sanofi-aventis U.S. "This approval is also an example of sanofi-aventis' commitment to further exploring our existing compounds and the potential benefit they bring to patients with serious diseases, such as in the areas of oncology and hematology."

Study Background

The primary objective of the multi-center, open-label, randomized, parallel group comparative study was to compare the safety and the effectiveness of three treatments (intravenous Elitek (rasburicase) alone daily for 5 days, intravenous Elitek daily for day 1 to day 3 followed by oral allopurinol daily for day 3 to day 5, and oral allopurinol alone daily for 5 days) in achieving uric acid response rate. The daily dose of Elitek was 0.20 mg/kg, while that of allopurinol was 300 mg. The PUA response rate was defined as the proportion of patients with PUA levels less than or equal to 7.5 mg/dL from day 3 to day 7 after initiation of treatment.

Results showed that among patients treated with Elitek alone or followed by oral allopurinol, uric acid levels were less than or equal to 2.0 mg/dL in 96% of patients (at 4 hours of the day 1 dose). There were no patients in either Elitek group with documented failure to control uric acid. In patients treated with Elitek alone (n=92), the PUA response rate was 87%, which was higher than that seen with patients treated with oral allopurinol alone (n=91) at 66% (p=0.0009), a statistically significant difference, or those treated with the Elitek/oral allopurinol combination (n=92) at 78%. The Elitek versus Elitek/oral allopurinol combination difference in PUA response rate was not statistically significant.

Antihyperuricemic treatment was extended beyond fiv
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