FDA Approves Asparaginase Erwinia Chrysanthemi for ALL
Friday, November 18, 2011
The US Food and Drug Administration approved asparaginase Erwinia chrysanthemi [ErwinazeTM, injection, EUSA Pharma (USA), Inc.] 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.
The approval was based on one clinical study in 58 patients with ALL who were unable to continue receiving pegaspargase or asparaginase derived from E. coli due to allergic reactions. The major efficacy outcome was attainment of sustained serum asparaginase activity levels of 0.1 IU/mL or higher, which is known to result in depletion of asparagine to levels that predict efficacy. Among 48 patients with available samples, all patients achieved this threshold trough level of asparaginase activity.
Safety was evaluated in 58 patients treated on the clinical study and in 574 patients treated on the Erwinaze Master Treatment Protocol (EMTP), an expanded access program.
The most serious adverse reactions included allergic reactions (including anaphylaxis), pancreatitis, abnormal transaminases, coagulopathies, hemorrhage, nausea, vomiting and hyperglycemia. Common adverse reactions were similar in severity and incidence to those attributable to E. coli-derived asparaginase.
The recommended dose and schedules for asparaginase Erwinia chrysanthemi are listed below.
In substitution for pegaspargase: 25,000 International Units/m2 administered intramuscularly three times a week (Monday/Wednesday/Friday) for six doses for each planned pegaspargase dose.
In substitution for native E. coli asparaginase: 25,000 International Units/m2 administered intramuscularly for each scheduled dose of native E. coli asparaginase within a treatment course.
Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125359lbl.pdf.
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).