New Form of Asparaginase Now Available in IV Form

Zosia Chustecka


December 22, 2014

The novel form of asparaginase, Erwinaze (Jazz Pharmaceuticals), for patients with acute lymphocytic leukemia (ALL) who have developed an allergy to Escherichia coli–derived products, is now available as an intravenous formulation, in addition to the already marketed intramuscular formulation.

Erwinaze was approved by the US Food and Drug Administration (FDA) in 2011 and was granted orphan drug status. It is used as part of a multiagent chemotherapeutic regimen for the treatment of ALL, which is the most common cancer in children.

The product is asparaginase derived from Erwinia chrysanthemi and is suitable for use in patients who have developed an allergy to the two currently available products, E coli–derived asparaginase (Elspar, Lundbeck) and E coli–derived pegaspargase (Oncaspar, Sigma-Tau Pharmaceuticals). Once a patient develops such an allergy, they are unable to continue with treatment.

An estimated 15% to 20% of patients with ALL develop a hypersensitivity to E coli–derived asparaginase, which extrapolates to approximately 450 to 600 children in the United States every year.

Now the FDA has approved the new intravenous formulation of the product. This approval was based on a pharmacokinetic study, which was conducted at 10 centers in the United States and enrolled a total of 30 patients who had become allergic to E coli–derived asparaginase. The company said that 24 patients were evaluable for the primary endpoint, which was the proportion of patients having an asparaginase activity level greater than 0.1 IU/mL 48 hours after dosing (preliminary results were reported previously [Blood. 2013;122:3904]).


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