FDA Expands Use for Leukemia Drug
Oncaspar OK'd to Treat Newly Diagnosed Acute Lymphoblastic Leukemia
July 26, 2006 -- Children and adults newly diagnosed with a certain type of leukemialeukemia may now use the drug Oncaspar as part of a multidrug chemotherapy regimen.
The FDA yesterday approved Oncaspar's use in treating newly diagnosed acute lymphoblastic leukemia (ALL) in combination with other chemo drugs.
Previously, Oncaspar was only an approved treatment for acute lymphoblastic leukemia patients who are allergic to Elspar (L-asparaginase), the disease's standard cancercancer drug.
Patients would get three Oncaspar injections instead of 21 Elspar injections over five months of treatment, according to an FDA news release.
"This treatment is a valuable alternative to current therapy," says Steven Galson, MD, MPH, in the FDA news release. Galson directs the FDA's Center for Drug Evaluation and Research.
The FDA approved Oncaspar's expanded use based on a study of 118 pediatric patients. The study showed that Oncaspar "could be safely and effectively substituted for Elspar as part of a multi-drug cancer regimen," states the FDA.
Acute Lymphoblastic Leukemia
Leukemia is a cancer of the white blood cells. Patients with acute leukemia have ineffective white blood cells that cannot help the body fight infections.
Acute lymphoblastic leukemia features an uncontrolled rise in lymphoblasts, which are an immature form of white blood cells called lymphocytes.
In acute lymphoblastic leukemia, the surge in lymphoblasts crowds the bone marrow. That leaves little room in the bone marrow for the body to make other types of blood cells.
Of the 25,000 new cases of leukemia expected in the U.S. this year, acute lymphoblastic leukemia accounts for about 2,500 cases in children and 4,000 in adults, according to the FDA.