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FDA approves Gleevec for children with ALL
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The FDA today approved the use of imatinib to treat children with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.
Acute lymphoblastic leukemia (ALL), the most common type of pediatric cancer, affects approximately 2,900 children annually. A genetic abnormality in children with Ph+ ALL causes tyrosine kinases to stimulate the bone marrow to make too many immature white blood cells.
Imatinib (Gleevec, Novartis), a tyrosine kinase inhibitor, blocks the proteins that promote the development of cancerous cells. The drug should be used in combination with chemotherapy to treat children with Ph+ ALL, according to the FDA.
The safety and effectiveness of imatinib in this patient population were established in a clinical trial conducted by the Children’s Oncology Group and sponsored by NCI.
Researchers enrolled 92 children and young adults aged 1 year and older with Ph+ ALL. Investigators divided patients into five treatment groups. Each successive group received a greater duration of imatinib plus chemotherapy.
Fifty patients received imatinib for the longest duration, and 70% of those patients went 4 years without relapse or death.
Patient deaths decreased with escalating duration of imatinib in combination with chemotherapy, researchers found.
Richard Pazdur
“We are pleased that the number of cancer medications for children are on the rise,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “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.”
The most common side effects observed in children with Ph+ ALL treated with imatinib and chemotherapy included decreased levels of neutrophils, decreased levels of blood platelets, liver toxicity and infection.
The FDA granted imatinib accelerated approval in 2001 to treat patients with blast crisis, accelerated phase or Ph+ chronic myeloid leukemia (CML) who failed interferon-alpha therapy. In 2011, the FDA approved the drug to treat newly diagnosed children with Ph+ CML. Imatinib was approved last year for adults with surgically removed Kit (CD117)-positive gastrointestinal stromal tumors.