New Form of Asparaginase for Leukemia Approved in US

Roxanne Nelson

November 18, 2011

November 18, 2011 — A new form of asparaginase has been approved in the United States for use in patients with acute lymphocytic leukemia (ALL). Erwinaze (EUSA Pharma) has been granted orphan drug status by the US Food and Drug Administration (FDA).

The product is asparaginase derived from Erwinia chrysanthemi,and is suitable for use in patients who have developed an allergy to the 2 currently available products, Escherichia coliderived asparaginase (Elspar) and E coli–derived pegaspargase (Oncospar). It is estimated that 15% to 20% of ALL patients develop a hypersensitivity to E coli–derived asparaginase, which extrapolates to approximately 450 to 600 children in the United States every year.

According to the manufacturer, the product will be available to patients in the United States immediately.

"Treatment with asparaginase is a vital and life-saving therapy for thousands of patients, mostly children, with acute lymphoblastic leukemia," said Stephen E. Sallan MD, chief of staff at the Dana-Farber Cancer Institute and professor of pediatrics at Harvard Medical School in Boston, Massachusetts, in a release. "Unfortunately, a number of these patients develop hypersensitivity to asparaginases derived from E coli, including pegaspargase, and are unable to complete the recommended course of treatment."

The approval of Erwinaze is an "important advance because it is the only treatment option that allows these patients to complete their full course of therapy," he added.

Patients receiving treatment with L-asparaginase derived from E coli who develop a hypersensitivity to that form of the enzyme might be able to safely continue their treatment with Erwinaze, according to the manufacturer. The enzymes are immunologically distinct, and antibodies that target E coli–derived L-asparaginase have not been shown to cross-react with Erwinaze.

The approval of Erwinaze is based on the results from clinical studies that involved 630 ALL patients. In a pivotal trial of 58 patients, the primary end point was the proportion of patients with sustained asparaginase activity levels, which correlate with better leukemia control and survival. The results showed that 100% of evaluable patients achieved the primary end point and maintained the prespecified threshold for asparaginase activity 48 or 72 hours after dosing.

Additional safety data were obtained from the Erwinaze Master Treatment Protocol, an expanded access program that enrolled 843 children with ALL or lymphoblastic lymphoma who received Erwinaze after developing a hypersensitivity to the standard treatment.

"The approval of Erwinaze underscores the FDA's commitment to the approval of drugs for conditions with limited patient populations with unmet medical needs," said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, in a statement.

Adverse events associated with Erwinaze include serious hypersensitivity, coagulation abnormalities, nausea, vomiting, and hyperglycemia.

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