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FDA approves new drug to treat acute lymphoblastic leukemia
Last reviewed: 01.07.2025
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White blood cells ( lymphocytes ) help the body fight infection, but acute lymphoblastic leukemia, also known as white blood cell cancer, is characterized by the production of excess lymphocytes in the bone marrow.
The US FDA has just approved a new drug called Erwinaze (Erwinia chrysanthemi asparaginase) from EUSA Pharma Inc Langhorne, which is indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) who are hypersensitive to the E. coli-derived chemotherapy drugs asparaginase and pegaspargase for the treatment of acute lymphoblastic leukemia.
Erwinaze works by destroying an amino acid (asparagine) that is essential for the growth of all cells in the human body. Erwinaze treatment consists of three intramuscular injections per week, causing leukemia cells to die. Erwinaze therapy does not affect healthy human cells.
Researchers evaluated the safety and efficacy of Erwinaze in a clinical trial involving 58 patients. Additional safety data from 843 patients were obtained from an expanded program called the Erwinaze Core Treatment Protocol (EMTP).
The criterion for the drug's effectiveness was a sufficient level of stable asparaginase in the patients' blood. The researchers noted that the pre-predicted asparaginase threshold at 48 or 72 hours after taking the drug was maintained in all patient groups.
Side effects associated with Erwinaze therapy: serious allergic reactions including anaphylactic shock, high levels of liver enzymes (transaminases and bilirubin) in the blood, bleeding (hemorrhage), inflammation of the pancreas (pancreatitis), nausea, vomiting, hyperglycemia.
The FDA approved two other products that contain asapargine, a specific enzyme, to treat patients with acute lymphoblastic leukemia before Erwinaze was approved, namely Elspar (asparaginase injection) and Oncaspar (pegaspargase), both of which are derived from E. coli.
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