Elitek (rasburicase, from sanofi-aventis), a recombinant urate oxidase enzyme, has been approved for the initial management of plasma uric acid (PUA) levels in adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis syndrome (TLS) and subsequent elevations of plasma uric acid. Elitek is indicated for only a single course of treatment.
This approval was based on results from a Phase 3, multicenter, open-label, randomized, parallel group comparative study comparing intravenous (IV) Elitek, IV Elitek followed by oral allopurinol, or oral allopurinol monotherapy. Among patients treated with Elitek alone or followed by allopurinol, uric acid levels were ≤2mg/dL in 96% of patients (at 4 hours of the day 1 dose). In patients treated with Elitek alone, the PUA response rate was 87%, higher than that seen with patients treated with allopurinol alone (66%), or those treated with the Elitek followed by allopurinol combination (78%)
Elitek is already indicated for a single course of treatment in the initial management of plasma uric acid levels in pediatric patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis syndrome and subsequent elevation of plasma uric acid.
For more information call (800) 446-6267 or visit www.elitekinfo.com.