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FDA Approves Oncaspar for Newly-Diagnosed Acute Lymphoblastic Leukemia
BETHESDA, MD -- July 25, 2006 -- The Food and Drug Administration (FDA) has expanded the approved use of Oncaspar (pegaspargase) to include treating children and adults with newly diagnosed acute lymphoblastic leukemia (ALL) as part of a multiple drug chemotherapy regimen.
FDA previously approved Oncaspar in 1994 only for patients with ALL who were unable to receive the cancer drug L-asparaginase because they were allergic to that drug.
Oncaspar is one of the first FDA-approved products that will come with prescription information in a new format designed to provide clear and concise information to health professionals.
"Today's announcement further demonstrates FDA's commitment to improving the quality of life for cancer patients. This treatment is a valuable alternative to current therapy," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research.
Leukemia is a cancer of the white blood cells; patients with acute leukemia have ineffective white blood cells that cannot help the body fight infections. An estimated 25,000 new cases of leukemia will be diagnosed in the United States during 2006. Of these new leukemia cases, approximately 6,500 will be the ALL type of leukemia, of which approximately 2,500 will occur in children and 4,000 will occur in adults.
The use of Oncaspar in place of the currently used drug, L-asparaginase, markedly reduces the number of drug injections required, from 21 injections of Elspar (L-asparaginase), which has been the standard of care, to three injections with Oncaspar over the 20-week course of treatment.
The approval is based on a randomized multi-center trial conducted by the Children's Cancer Group, a National Cancer Institute-funded cooperative oncology group, in 118 pediatric patients. In the trial, researchers demonstrated that Oncaspar could be safely and effectively substituted for Elspar as part of a multi-drug cancer regimen.
Serious side effects with Oncaspar include anaphylaxis (allergic shock), other serious allergic reactions, blood clots, stroke, pancreatitis, glucose intolerance and bleeding problems.
SOURCE: Food and Drug Administration
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