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FDA approves intravenous administration of Enzon cancer drug

The FDA has approved a change in the labeling of Enzon Pharmaceuticals' pediatric oncology treatment, Oncaspar, allowing the drug to be administered intravenously.

Previously, Oncaspar’s administration was limited to intramuscular administration, which involves injecting the drug directly into the muscle and is often painful to patients.

Intravenous administration provides clinicians with a new option that will potentially reduce the number of injections for pediatric cancer patients who require Oncaspar in their treatment regimen.

Oncaspar is a PEG-enhanced version of the naturally occurring enzyme L-asparaginase. L-asparaginase is an enzyme that depletes the amino acid asparagine, which certain leukemic cells are dependent upon for survival.

Oncaspar was granted a marketing license by the FDA in February 1994 to treat patients with acute lymphoblastic leukemia who require L-asparaginase in their treatment regimen, but have developed hypersensitivity to native forms of L-asparaginase.