FDA approves Gleevec for most common pediatric cancer

Drug approved for Ph+ ALL

SILVER SPRING, Md. — The Food and Drug Administration has approved a Novartis drug for treating leukemia in children.

The FDA said Friday that it approved Gleevec (imatinib) for treating children newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia, also known as Ph+ ALL.

ALL is the most common type of cancer in children, the FDA said, affecting about 2,900 children per year. In children with Ph+ ALL, a genetic abnormality causes proteins called tyrosine kinases to stimulate the bone marrow to make too many immature white blood cells, leaving less room for healthy white blood cells to fight infection.

"We are pleased that the number of cancer medications for children are on the rise," FDA office of Hematology and Oncology Products director Richard Pazdur said. "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."


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