FDA Expands Oncaspar Use for Acute Lymphoblastic Leukemia
Oncaspar can be safely substituted for L-asparaginase in ALL patients
TUESDAY, July 25 (HealthDay News) -- The U.S. Food and Drug Administration has expanded the use of Oncaspar to include the treatment of children and adults with newly diagnosed acute lymphoblastic leukemia (ALL) who are receiving a multi-drug chemotherapy regimen.
Initially approved in 1994, Oncaspar was previously used only to treat patients with ALL who were allergic to the standard-of-care, L-asparaginase. The use of Oncaspar in place of L-asparaginase will reduce the number of drug injections from 21 required for L-asparaginase to three required for Oncaspar over the 20-week course of treatment.
FDA approval was based on a randomized multi-center trial of 118 pediatric patients called the Children's Cancer Group, a National Cancer Institute-funded cooperative oncology group. Serious side effects of Oncaspar include anaphylaxis, other allergic reactions, blood clots, stroke, pancreatitis, glucose intolerance and bleeding problems.
Oncaspar is one of the first FDA-approved products to come with prescription information in a new format that provides clear and concise information to physicians.
Oncaspar is marketed by Enzon Pharmaceuticals in Bridgewater, N.J.