Lymphoma Research Foundation News Room:

FDA Approves Use of Rasburicase to Manage Plasma Uric Acid Levels in Adults at Risk for Tumor Lysis 

U.S. Food and Drug Administration approves drug to prevent tumor lysis syndrome in adults with hematologic cancers.

The U.S. Food and Drug Administration (FDA) recently approved expanded marketing for rasburicase (Elitek) for the initial management of plasma uric acid (PUA) and prevention of tumor lysis syndrome (TLS) in adult patients receiving anti-cancer treatment for leukemia, lymphoma and solid tumor malignancies. Previously, the drug was only approved for pediatric use.

Potentially life-threatening, TLS consists of complications that arise from tumor breakdown when the body loses its ability to rid itself of the excess metabolic by-products. It is clinically defined by changes in at least two or more laboratory parameters, namely heightened blood levels of PUA (hyperuricemia), potassium (hyperkalemia) or phosphate (hyperphosphatemia) and low blood levels of serum calcium (hypocalcemia), along with at least one of the following clinical events occurring within seven days of treatment: renal failure/injury, need for dialysis, and/or serum creatinine increase greater than 1.5 x ULN, arrhythmia or seizure (according to the Cairo-Bishop criteria).

This approval comes after release of Phase III clinical trial results showing that the intravenous infusion rasburicase was more effective in controlling PUA levels in adults than the standard therapy, oral allopurinol, and therefore more likely to prevent TLS.

This new therapeutic option will give doctors more flexibility when treating adult patients with hematologic cancers at risk for TLS and elevated PUA levels.

To read the press release from Sanofi-aventis, click here.

10/22/09