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FOR IMMEDIATE RELEASE |
Media Inquiries: 301-827-6242 |
The Food and Drug Administration (FDA) today announced the approval of Gleevec (imatinib mesylate) tablets for the treatment of pediatric patients with Philadelphia chromosome positive(Ph+)chronic myeloid leukemia (CML) in chronic phase — a rare, life-threatening form of cancer that accounts for approximately two percent of all leukemias in children.
Gleevec is indicated for children whose disease has recurred after stem cell transplant or who are resistant to interferon alpha therapy.
This drug was approved under the accelerated approval program. The program
helps make products for serious or life-threatening diseases available earlier
in the development process by allowing approval to be based on a promising effect
of the drug, such as tumor shrinkage. As of yet, there are no controlled trials
demonstrating
clinical benefit, such as improvement in disease-related symptoms or increased
survival. Subsequent studies after approval will be conducted to confirm that
the drug has improved survival or other clinical benefits in pediatric patients.
“Gleevec was originally granted accelerated approval two years ago for certain kinds of leukemia in adults, and now has been shown to be a valuable treatment for certain leukemias in children that do not respond to other treatments,” said FDA Commissioner Mark B. McClellan, M.D., Ph.D. “ With follow up studies to confirm its benefits, Gleevec illustrates the type of significant medical advance for children that can be achieved quickly under FDA’s accelerated approval program.”
“Today’s approval is the first approval of a new pediatric cancer drug treatment in over a decade,” added Dr. McClellan. “We hope to see more products developed that improve pediatric cancer care, and we are working to facilitate their development and timely approval.”
In addition to its original approved indication for CML refractory to other
treatments in adults, and expansion
to use as a first line treatment for CML, Gleevec was also previously granted
accelerated approval for the treatment of gastrointestinal stromal cancer in
February, 2002.
Today’s accelerated approval of Gleevec for pediatric use is based on extrapolation of results from Gleevec treated adults with CML together with good responses in a small number of children.
As a condition of approval Novartis has agreed to conduct pediatric studies after approval to gain greater insight into the drug’s use in children.
The most frequently reported adverse events reported with the use of Gleevec are nausea, vomiting, diarrhea, edema(sometimes severe), and muscle cramps. A considerable reduction in white blood cells and platelets was also reported with Gleevec treatment.
The recommended dosage for pediatric populations is 260mg/m2/day. In children, Gleevec treatment can be given as a once daily dose or, alternatively, the daily dose may be split in two-once in the morning and once in the evening.
Gleevec is manufactured by Novartis Pharma AG for Novartis Pharmaceuticals Corporation located in East Hanover, N.J.
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