07.25.06
Enzon Pharmaceuticals received approval from the FDA for its sBLA for Oncaspar, an oncology product for use as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of patients with acute lymphoblastic leukemia (ALL). Oncaspar had previously been indicated for patients with ALL who require L-asparaginase in their treatment, but developed hypersensitivity to the native forms.
The FDA approved the new first-line indication for Oncaspar based on data from two studies conducted by the Children's Cancer Group (CCG), CCG-1962 and CCG-1991, with safety data from more than 2,000 pediatric patients.
Acute Lymphoblastic Leukemia is an aggressive blood cancer, which will affect almost 4,000 people in 2006, according to the American Cancer Society. ALL is the most common form of cancer in children, representing 23% of cancer diagnoses among those younger than 15 years of age.
The FDA approved the new first-line indication for Oncaspar based on data from two studies conducted by the Children's Cancer Group (CCG), CCG-1962 and CCG-1991, with safety data from more than 2,000 pediatric patients.
Acute Lymphoblastic Leukemia is an aggressive blood cancer, which will affect almost 4,000 people in 2006, according to the American Cancer Society. ALL is the most common form of cancer in children, representing 23% of cancer diagnoses among those younger than 15 years of age.