FDA Approves Rasburicase for Use in Adult Cancer Patients

Yael Waknine

October 21, 2009

October 21, 2009 — The US Food and Drug Administration (FDA) has approved an expanded indication for rasburicase intravenous infusion (Elitek, sanofi-aventis US, Inc) for the initial management of plasma uric acid (PUA) levels in adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to cause tumor lysis and subsequent elevation of PUA levels. Rasburicase previously was approved for pediatric use only.

"The approval of Elitek in adult patients with cancer now provides physicians with an important new option for managing elevated [PUA,] which could result in tumor lysis syndrome, a potentially life-threatening complication that can develop from anti-cancer therapy," said principal investigator Dr. Jorge Cortes in a company news release. Dr. Cortes is professor of medicine and deputy chair, Department of Leukemia, University of Texas, M.D. Anderson Cancer Center, in Houston.

Approval of the expanded indication was based on data from a pivotal phase 3 trial showing that rasburicase was significantly more effective than allopurinol, the current standard of care, for reducing PUA levels in adults at risk for tumor lysis syndrome. Patients considered at high risk for tumor lysis syndrome either had elevated PUA levels resulting from malignancy or had been diagnosed with very aggressive hematologic malignancies such as leukemia and lymphoma.

For the study, 275 adult cancer patients were randomly assigned to receive 0.20 mg/kg intravenous rasburicase for 5 days, 300 mg oral allopurinol for 5 days, or combination therapy consisting of rasburicase on days 1 to 3, followed by allopurinol on days 3 to 10.

Initial results showed that 96% of rasburicase-treated patients achieved uric acid levels of 2.0 mg/dL or less within 4 hours of the first dose.

As the study progressed, the proportion of patients achieving PUA levels of 7.5 mg/dL or less from days 3 to 7 was found to be significantly higher in patients receiving rasburicase vs allopurinol monotherapy (87% vs 66%; P = .0009); the difference in PUA response rates between the rasburicase-alone and combination therapy groups did not achieve statistical significance (87% vs 78%).

None of the patients receiving rasburicase monotherapy required extension of antihyperuricemic therapy beyond 5 days; additional treatment was required in 4.4% of those patients receiving allopurinol alone and 6.5% of patients receiving combination therapy. The incidence of tumor lysis syndrome was similar between groups (3%, 4%, and 3%, respectively).

Serious adverse events reported more commonly with rasburicase than allopurinol (difference ≥ 2%) included pulmonary hemorrhage, respiratory failure, supraventricular arrhythmias, ischemic coronary artery disorders, and abdominal and gastrointestinal infections.

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