Date: 2012-12-10
Type of information:
phase:
Announcement: presentation of results at the American Society of Hematology (ASH) Annual Meeting.
The poster, titled \"L-Asparaginase (L-ASP) Related Toxicities with Asparaginase Erwinia Chrysanthemi in a Large Compassionate Use Protocol,\" was presented by Paul V. Plourde , M.D., senior vice president of clinical oncology at Jazz Pharmaceuticals .
Company: Jazz Pharmaceuticals (Ireland)
Product: Erwinaze® (asparaginase Erwinia chrysanthemi)
Action mechanism:
Disease: acute lymphoblastic leukemia (ALL)
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: Jazz Pharmaceuticals plc has announced that data from the largest safety trial to date of patients treated with Erwinaze® (asparaginase Erwinia chrysanthemi) have been presented at the American Society of Hematology Annual Meeting. The poster presentation is based on results of a compassionate use protocol in patients who received Erwinaze® as part of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia who developed a hypersensitivity to E.coli-derived asparaginase. The poster summarizes the safety results in 940 patients at participating U.S. oncology treatment centers between February 2006 and November 2011 , when Erwinaze® was available under a compassionate use protocol prior to its approval by the FDA in November 2011. The trial includes additional follow up data that further describe the incidence of adverse events associated with Erwinaze® treatment, which are consistent with the known safety profile of Erwinaze. \"The extensive information collected in this study provides important information that further evaluates the safety profile of Erwinaze®,\" stated Jeffrey Tobias , MD, executive vice president of research and development and chief medical officer of Jazz Pharmaceuticals . \"This additional information may help physicians as they make important treatment decisions related to Erwinaze®.\"
