The FDA today approved Erwinaze (asparaginase Erwinia chysanthemi) to treat patients with acute lymphoblastic anemia (ALL), who have developed an allergy to E. coli derived asparaginase and pegaspargase chemotherapy drugs used to treat ALL.
Acute lymphoblastic leukemia is a type of cancer in which the bone marrow produces too many lymphocytes, a type of white blood cell. White blood cells constitute the body’s defense mechanism against 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 essential for the growth of all cells. Leukemia cells cannot produce this protein building block, and thus when a patient is treated with Erwinaze the leukemia cells die. Normal human cells are able to make enough asparagine to meet their own needs through biosynthesis and will not be affected by treatment with Erwinaze.
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 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 is manufactured by EUSA Pharma Inc. of Langhorne, Pa.