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FDA Expands Use of Gleevec (Imatinib) to Include Children With ALL

Drug already approved for several conditions, including CML and GIST (Jan. 25)

The FDA has approved a new use of Gleevec (imatinib, Novartis) to treat children newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).

ALL is the most common type of pediatric cancer, affecting approximately 2,900 children annually, and progresses quickly if untreated. Children with Ph+ ALL have a genetic abnormality that causes tyrosine kinase proteins 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.

Gleevec (imatinib), a tyrosine kinase inhibitor, blocks the proteins that promote the development of cancerous cells. It should be used in combination with chemotherapy to treat children with Ph+ ALL.

The safety and effectiveness of this new indication were established in a clinical trial sponsored by the National Cancer Institute. The study enrolled children and young adults aged 1 year and older with very-high-risk ALL — defined as patients with a greater than 45% chance of experiencing complications from their disease within 5 years of treatment. Ninety-two patients with Ph+ ALL were randomly assigned to five treatment groups, with each successive group receiving a greater duration of Gleevec treatment in combination with chemotherapy.

Fifty of the Ph+ ALL patients received Gleevec for the longest duration, and 70% of these patients did not experience relapse or death within 4 years (event-free survival). In addition, patient deaths decreased with increasing duration of Gleevec treatment in combination with chemotherapy.

The most common side effects observed in children with Ph+ ALL treated with Gleevec in combination with chemotherapy included decreased levels of neutrophils and blood platelets, liver toxicity, and infection.

Gleevec (imatinib) was granted accelerated approval in 2001 to treat patients with accelerated-phase or chronic-phase Ph+ chronic myeloid leukemia (CML) in blast crisis who failed interferon-alpha therapy. The drug was later approved to treat several conditions, including newly diagnosed Ph+ CML in children (2011) and Kit (CD117)-positive gastrointestinal stromal tumors (GIST) that have been surgically removed in adults (2012).

Source: FDA; January 25, 2013.

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