Rasburicase Approved to Manage Complications of Anticancer Therapy

Sanofi-aventis US announced that the US Food and Drug Administration (FDA) has granted marketing approval for rasburicase (Elitek) to be used 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 result in tumor lysis syndrome (TLS) and subsequent elevations of plasma uric acid.

The FDA approval was based on pivotal phase III trial results demonstrating that rasburicase significantly reduced PUA levels compared to the current standard of care (oral allopurinol) in adults with hematologic cancers at risk for the potentially life-threatening complication of TLS. Patients considered at high risk for TLS either had an elevated level of PUA (hyperuricemia) due to a malignancy, or were diagnosed with a very aggressive hematologic malignancy (leukemia or lymphoma).

Clinical TLS was defined by changes in at least two or more laboratory parameters, namely hyperuricemia, hyperkalemia, hyperphosphatemia, and hypocalcemia, along with at least one of the following clinical events occurring within 7 days of treatment: renal failure/injury, need for dialysis, and/or serum creatinine increase greater than 1.5 × upper limit of normal, arrhythmia, or seizure (according to the Cairo-Bishop criteria).