The U.S. Food and Drug Administration recently approved Erwinaze (asparaginase Erwinia chrysanthemi) to treat patients with acute lymphoblastic leukemia (ALL), who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegapargase chemotherapy drugs used to treat ALL.
Acute lymphoblastic leukemia is a type of cancer in which the bone marrow makes too many lymphocytes, a type of white blood cell. White blood cells help the body fight 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 necessary for the growth of all cells. Leukemia cells cannot produce this protein building block. When a patient is treated with Erwinaze the leukemia cells die. Normal human cells are able to make enough asparagine for their own needs through biosynthesis and will not be affected by treatment with Erwinaze.
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.