FDA Approves Elitek for Management of Plasma Uric Acid Levels in Adults with Leukemia, Lymphoma, and Solid Tumors Receiving Anti-Cancer Therapy
Mon, 10/19/2009 - 6:02am
Sanofi-aventis U.S. has announced that the FDA has granted marketing approval for Elitek® (rasburicase) 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 anti-cancer therapy expected to result in tumor lysis syndrome (TLS) and subsequent elevations of plasma uric acid. The FDA's approval was based on pivotal Phase 3 trial results which demonstrated that Elitek significantly reduced PUA levels when 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). "The approval of Elitek in adult patients with cancer now provides physicians with an important new option for managing elevated plasma uric acid 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, Professor of Medicine and Deputy Chair, Department of Leukemia at The University of Texas, M.D. Anderson Cancer Center, in Houston, Texas. 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 x ULN, arrhythmia or seizure (according to the Cairo-Bishop criteria). "We are very proud that Elitek - which has already been shown to bring significant treatment benefits to pediatric patients at risk of developing this complication - has now been approved by the U.S. Food and Drug Administration to help adult patients as well," said Dr. Paul Chew, Senior Vice President, U.S. Chief Science Officer/Chief Medical Officer of sanofi-aventis U.S. "This approval is also an example of sanofi-aventis' commitment to further exploring our existing compounds and the potential benefit they bring to patients with serious diseases, such as in the areas of oncology and hematology."