FDA Approval for Asparaginase Erwinia chrysanthemi
Brand name: ErwinazeTM
- Approved for acute lymphoblastic leukemia patients with hypersensitivity to E. coli-derived asparaginase.
Full prescribing information is available, including clinical trial information, safety, dosing, drug-drug interactions and contraindications.
On November 18, 2011, the Food and Drug Administration (FDA) approved asparaginase Erwinia chrysanthemi [ErwinazeTM, injection, made by 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 International Units /mL or higher, which has been demonstrated to correlate with asparagine depletion (asparagine < 0.4 mcg/mL or 3 μM) and to serum levels that predict clinical 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.
This summary was provided by Richard Pazdur, M.D., director of the FDA's Division of Oncology Drug Products.
The FDA is the division of the U.S. Department of Health and Human Services charged with ensuring the safety and effectiveness of new drugs and other products. (See "Understanding the Approval Process for New Cancer Treatments.") The FDA's mission is to promote and protect the public health by helping safe and effective products to reach the market in a timely way, and monitoring products for continued safety after they are in use.