ENZON'S ONCASPAR APPROVED AS FIRST-LINE LEUKEMIA TREATMENT

The FDA has approved Enzon Pharmaceuticals' supplemental biologics license application for its acute lymphoblastic leukemia (ALL) drug Oncaspar, the agency said.

Oncaspar (pegaspargase) is approved as part of a multiple drug chemotherapy regime for adults and children with ALL. The FDA first approved Oncaspar in 1994 to treat only those patients who were allergic to another cancer drug, Elspar (L-asparaginase). Only three injections of Oncaspar are required over a 20-week course of treatment, compared to 21 injections of Elspar, the FDA said.

Oncaspar kills leukemia cells by breaking down an amino acid, asparagine, which is necessary to the survival of both leukemia and normal cells. Normal cells can produce more asparagine, but leukemia cells cannot. Without treatment, most patients do not survive more than five months, Enzon said.

Sales of Oncaspar rose 33 percent, from $9.8 million to $13 million, for the six months ended December 2005 compared to the same period in 2004.