The FDA approved asparaginase Erwinia chrysanthemi (Erwinaze, Eusa Pharma) for the treatment of acute lymphoblastic leukemia (ALL) in patients with hypersensitivity to Escherichia coli–associated asparaginase and pegaspargase chemotherapy drugs used for the treatment of ALL. The approval was based on a singlearm, multicenter, open-label phase 3 trial that enrolled 58 patients with ALL who had discontinued previous pegaspargase therapy in response to hypersensitivity reactions.All patients received 25,000 IU/m2 of asparaginase E chrysanthemi in 6 doses over 2 weeks as a replacement for the pegaspargase dose remaining in their original treatment protocol. At 48 hours and 72 hours after the third dose, 100% of 48 evaluable patients had a serumtrough asparaginase level ?0.1 IU/mL, the primary end point. Adverse effects reported were anaphylaxis, pancreatitis, elevated transaminiase and bilirubin levels, blood clotting, hemorrhage, nausea, vomiting, and hyperglycemia. (November 18, 2011)
