FDA Approves Erwinaze to Treat a Form of Leukemia
SILVER SPRING, Md., Nov. 18, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today 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 pegaspargase 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.
"The approval of Erwinaze underscores the FDA's commitment to the approval of drugs for conditions with limited patient populations with unmet medical needs using novel trial endpoints," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.
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 suppo