For Immediate Release: Nov. 18, 2011
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA approves Erwinaze to treat a form of leukemia
The U.S. Food and Drug Administration today approved Erwinaze (asparaginase Erwinia chrysanthemi) to treat patients with acute lymphoblastic leukemia (ALL), who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegapargase chemotherapy drugs used to treat ALL.
Acute lymphoblastic leukemia is a type of cancer in which the bone marrow makes too many lymphocytes, a type of white blood cell. White blood cells help the body fight infection and are formed in the bone marrow.
Erwinaze is injected directly into the muscle three times a week and works by breaking down one of the body’s protein building blocks (the amino acid, asparagine) that is present in the blood, and is necessary for the growth of all cells. Leukemia cells cannot produce this protein building block. When a patient is treated with Erwinaze the leukemia cells die. Normal human cells are able to make enough asparagine for their own needs through biosynthesis and will not be affected by treatment with Erwinaze.
“The approval of Erwinaze underscores the FDA’s commitment to the approval of drugs for conditions with limited patient populations with unmet medical needs using novel trial endpoints” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
The safety and effectiveness of Erwinaze was evaluated in one clinical trial of 58 patients. Additional safety data was collected from the Erwinaze Master Treatment Protocol (EMTP), an expanded access program that enrolled 843 patients. Patients in both studies were unable to continue receiving pegaspargase or asparaginase derived from E. coli due to allergic reactions.
In the trial to support efficacy, the main outcome (endpoint) was the measurement of the proportion of patients with sustained asparaginase activity levels that correlate with better leukemia control and survival. All evaluable patients were shown to have maintained the pre-specified threshold for asparaginase activity at 48 or 72 hours after dosing.
Side effects associated with Erwinaze treatment include serious allergic reactions (anaphylaxis), inflammation of the pancreas (pancreatitis), high blood levels of liver enzymes (abnormal transaminases and bilirubin), blood clotting, bleeding (hemorrhage), nausea, vomiting and high blood sugar (hyperglycemia).
Prior to Erwinaze’s approval there were two asparagine specific enzyme products – Elspar (asparaginase injection) and Oncaspar (pegaspargase) – approved by FDA to treat patients with ALL. Both of these products are E. coli derived.
Erwinaze has been designated as an orphan drug, which identifies the disease as affecting fewer than 200,000 people in the U.S.
Erwinaze is manufactured by EUSA Pharma Inc. of Langhorne, Pa.
For more information:
Press Announcements > FDA approves Erwinaze to treat a form of leukemia
Erwinia chrysanthemiOn November 18, 2011, the U. S. Food and Drug Administration approved asparaginase Erwinia chrysanthemi [Erwinaze, 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.pdf1
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.htm2, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).
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