Elitek FDA-approved for recombinant uricolytic agent for tumor lysis

Rasburicase (Elitek) has been granted FDA approval for the initial management of plasma uric acid (PUA) levels in adult patients with leukemia, lymphoma, and solid tumor malignancies.

The approval was based on phase III trial results, which demonstrated that rasburicase significantly reduced PUA levels when compared to the current standard of care, oral allopurinol (Zyloprim), in adults with hematologic cancers at risk for tumor lysis syndrome, according to Sanofi-aventis (ASH 2008 abstract 919).

Rasburicase is a recombinant urate oxidase enzyme. It is now indicated at a daily dose of .20 mg/kg intravenously for up to five days for the initial management of PUA levels.