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The U.S. Food and Drug Administration has approved a new indication for Gleevec (imatinib), the life-saving drug first developed for chronic myeloid leukemia patients by Brian Druker and approved in 2001.
This latest indication approves the drug for the treatment of children with newly diagnosed Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL), which is the most frequently diagnosed pediatric cancer. These patients have a genetic abnormality that causes proteins called tyrosine kinases to stimulate the bone marrow to make too many immature white blood cells. This leaves less room for healthy white blood cells needed to fight infection.
The National Cancer Institute estimates that slightly less than 3,000 children receive the diagnosis annually. If left untreated, ALL can progress very rapidly.
Gleevec is a tyrosine kinase inhibitor, and it acts by blocking the proteins that promote the development of those cancerous cells. The FDA is recommending that Gleevec be used in combination with chemotherapy to treat this patient population.
“We are pleased that the number of cancer medications for children are on the rise,” Said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval is the result of continuous interactions among the FDA, the Children’s Oncology Group and the National Cancer Institute to provide new and better treatments to American children with cancer.”