Cancer Drug Approved for Childhood Leukemia

FDA grants 4th use for Gleevec

TUESDAY, May 20, 2003 (HealthDayNews) -- Gleevec (imatinib mesylate) has received its fourth Food and Drug Administration approval in two years, this time for a rare, life-threatening form of childhood leukemia.

The latest action is for a form of Philadelphia chromosome positive chronic myeloid leukemia (CML), which accounts for about 2 percent of all leukemias in children. The approval applies to children whose disease has recurred after a stem cell transplant or who are resistant to interferon therapy.

The accelerated approval was granted under an FDA program that allows drugs for life-threatening conditions to be marketed before their safety and effectiveness is entirely known. As a condition of approval, Gleevec's manufacturer, Novartis Pharmaceuticals Corp., will be required to conduct additional studies on children.

Two years ago, Gleevec received an FDA nod as a treatment for CML in adults, an approval that was later expanded. The latest approval was based on the drug's performance in a small number of tests on children, the agency says.

Gleevec is also approved to treat gastrointestinal stromal cancer. Side effects include nausea, vomiting, diarrhea, swelling (edema), and muscle cramps.

Here is the FDA Talk Paper announcing the approval. For more information about CML, visit the National Cancer Institute.

Scott Roberts

Scott Roberts

Published on May 20, 2003

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