Sanofi Aventis Gets Marketing Approval For Elitek

The FDA has granted marketing approval to Sanofi Aventis, US, for Elitek (rasburicase), for the initial management of plasma uric acid (PUA) levels in adult patients with leukemia, lymphoma, and solid tumor malignancies. Reportedly, Elitek is a recombinant urate oxidase enzyme. It is the first recombinant uricolytic agent approved in the US to maintain PUA levels in patients receiving anti-cancer therapy.

The 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.

Jorge Cortes, principal investigator and deputy chair at department of leukemia at MD Anderson Cancer Center of University of Texas, said: “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.”

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).