Enzon's leukemia drug Oncaspar gets FDA approval

By Elaine Rigoli

Tampa, Fla., July 25 - Enzon Pharmaceuticals, Inc. said the Food and Drug Administration has approved the company's supplemental Biologics License Application for its oncology product, Oncaspar (pegaspargase) for use as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of patients with acute lymphoblastic leukemia.

Oncaspar had previously been indicated for patients with acute lymphoblastic leukemia who require L-asparaginase in their treatment, but developed hypersensitivity to the native forms, the company said in a news release.

The FDA approved the new first-line indication for Oncaspar based on data from two studies conducted by the Children's Cancer Group, CCG-1962 and CCG-1991, with safety data from more than 2,000 pediatric patients.

Enzon is a biopharmaceutical company with headquarters in Bridgewater, N.J.

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