The U.S. FDA today approved Erwinaze (asparaginase Erwinia chrysanthemi) for the treatment of acute lymphoblastic leukemia (ALL), that have developed a hypersensitivity (hypersensitivity) to E. coli derived asparaginase and pegaspargase chemotherapy medications used to treat ALL(acute lymphoblastic leukemia). Acute lymphoblastic leukemia is a form of cancer where the bone marrow makes a lot of lymphocytes, a kind of white blood cell. White blood cells help the body fight infection and so are formed within the bone marrow.
The medication of Erwinaze is injected directly into the muscle 3 times weekly and operates by deteriorating one of many body’s protein foundations (the amino acid, asparagine) which is present in the blood, and is required for the development of cells. An individuals’ cell suffering from Leukemia cannot produce this protein source. When a patient is addressed with Erwinaze the leukemia cells die. Normal human cells have the ability to make enough asparagine for his or her own needs through biosynthesis and will not have treatment with Erwinaze.
“The approval of Erwinaze underscores the FDA’s commitment to the approval of pills for conditions with limited patient populations with unmet medical needs using novel trial endpoints,” said Richard Pazdur, M.D., director from the Office of Hematology and Oncology Products inside the FDA’s Center for Drug Evaluation and Research.
The clinical study for the protection and effectiveness of Erwinaze was evaluated on 58 patients. Additional safety data was collected from your Erwinaze Master Treatment Protocol (EMTP), an expanded access program that enrolled 843 patients. Patients in the studies were not able to continue receiving pegaspargase or asparaginase derived from E. coli as a result of allergies. Inside the trial to support efficacy, the main outcome (endpoint) was the measurement from the proportion of patients with sustained asparaginase activity levels that correlate with better leukemia control and survival.
Unwanted effects associated with Erwinaze treatment includes serious allergy symptoms (anaphylaxis), inflammation with the pancreas (pancreatitis), high blood degrees of liver enzymes (abnormal transaminases and bilirubin), blood clotting, bleeding (hemorrhage), nausea, vomiting and high blood sugar levels (hyperglycemia).