Enzon Pharmaceuticals Inc. received an approval from the US Food and Drug Administration for a labelling change for its paediatric oncology drug, Oncaspar. The new labelling allows for administration via the intravenous (IV) route.

According to a company release, IV administration provides clinicians with an important new option that will potentially reduce the number of injections for paediatric cancer patients who require Oncaspar in their treatment regimen. Previously, Oncaspar's administration was limited to intramuscular administration, which involves injecting the drug directly into the muscle and is often painful to patients.

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 leukaemia cells are dependent upon for survival. Oncaspar was granted a marketing license by the US Food and Drug Administration in February 1994 to treat patients with acute lymphoblastic leukaemia who require L-asparaginase in their treatment regimen, but have developed hypersensitivity to native forms of L-asparaginase.

Through its proprietary pegylation technology, Enzon designed Oncaspar to offer therapeutic advantages over unmodified L-asparaginase. In addition to reduced immunogenicity, Oncaspar provides a more convenient, patient-friendly dosing regimen that allows for administration every 14 days, versus twice weekly for unmodified L-asparaginase. Enzon's specialised oncology sales force markets Oncaspar in North America.

About 35,000 new cases of leukaemia will be diagnosed in the United States during 2005. Of these about 4,000 will be acute lymphoblastic leukaemia (also called acute lymphocytic leukaemia or ALL). Although ALL is mainly a childhood leukaemia, about one-third of new cases will occur in adults.

Enzon Pharmaceuticals Inc. is a biopharmaceutical company dedicated to the development and commercialisation of therapeutics to treat patients with cancer and other life-threatening diseases.