FDA approved a new drug for the treatment of acute lymphoblastic leukemia
Last reviewed: 23.04.2024
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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 (asparaginase Erwinia chrysanthemi) manufactured by EUSA Pharma Inc Langhorne, which is designed to treat patients with acute lymphoblastic leukemia (ALL) with increased sensitivity to chemotherapy drugs asparaginase and pegasaspase from E.coli for treatment of acute lymphoblastic leukemia.
The mechanism of action of Erwinaze is the destruction of the amino acid (asparagine), necessary for the growth of all cells of the human body. Erwinaze treatment consists of three intramuscular injections per week, as a result of which leukemia cells die. Erwinaze therapy does not affect healthy human cells.
The 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 extended program called the "main protocol for the treatment of Erwinaze" (EMTP).
The criterion for the effectiveness of the drug was a sufficient level of stable asparaginase in the blood of patients. The researchers noted that the predicted asparaginase threshold at 48 or 72 hours after taking the drug persisted in all patient groups.
Side effects associated with Erwinaze therapy: severe allergic reactions, including anaphylactic shock, high levels of hepatic enzymes (transaminases and bilirubin) in the blood, bleeding (hemorrhage), pancreatic inflammation (pancreatitis), nausea, vomiting, hyperglycemia.
The FDA approved two other products that contain asapargine, a specific enzyme for the treatment of patients with acute lymphoblastic leukemia before Erwinaze approval, namely Elspar (asparaginase injection) and Oncaspar (pegaspargase), both of which are derived from E. Coli.
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