Date: 2014-12-19
Type of information: Granting of a Market Authorisation in the US
Product name: Erwinaze® (intravenous administration)
Compound: asparaginase Erwinia chrysanthemi
Therapeutic area: Cancer - Oncology
Action mechanism: Erwinaze® (asparaginase Erwinia chrysanthemi) is currently approved in the U.S. for administration via intramuscular injection or via intravenous infusion in conjunction with chemotherapy. It is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase. Erwinaze is derived from the bacterium Erwinia chrysanthemi and is therefore immunologically distinct from E. coli-derived asparaginase and suitable for patients with hypersensitivity to E. coli-derived treatments3. Outside of the U.S., Erwinaze® is sold under the name Erwinase®.
Company: Jazz Pharmaceuticals (Ireland)
Disease: patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase
Latest news: * On December 19, 2014, Jazz Pharmaceuticals announced that the FDA approved the intravenous administration of Erwinaze® (asparaginase Erwinia chrysanthemi). Erwinaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase. Prior to this approval, the only approved route of administration for Erwinaze® was through intramuscular injection. With the expanded label, the formulation of Erwinaze® currently on the market may now be administered to patients by either intravenous infusion or intramuscular injection. The updated product label provides data and information to help physicians understand the different administration options and determine which route of administration is most appropriate for their patients. The FDA approval was based on a pharmacokinetic study of intravenous asparaginase Erwinia chrysanthemi following hypersensitivity to E coli-derived asparaginase. The intravenous administration trial was conducted at 10 centers in the U.S. and recruited a total of 30 patients, of which 24 patients were evaluable for the primary endpoint, which was the proportion of patients having an asparaginase activity level of greater than 0.1 IU/mL 48 hours after dosing. The server is temporarily unable to service your
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