REGULATORY AFFAIRS

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FDA Approves Gleevec for Children with Acute Lymphoblastic Leukemia

 

Acute lymphoblastic leukemia (ALL) is the most common type of pediatric cancer, affecting approximately 2,900 children annually, and progresses quickly if untreated. Children with Philadelphia chromosome positive (Ph+) ALL have a genetic abnormality that causes proteins called tyrosine kinases 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.

 

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

 

Gleevec’s safety and effectiveness for this new indication were established in a clinical trial conducted by the Children’s Oncology Group, sponsored by the National Cancer Institute. The trial enrolled children and young adults 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 five years of treatment. Ninety-two patients with Ph+ ALL were enrolled in the trial and divided into 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 four years (event-free survival). Results also showed patient deaths decreased with increasing duration of Gleevec treatment in combination with chemotherapy. The most common side effects included decreased levels of infection-fighting blood cells called neutrophils; decreased levels of blood platelets, which assist in blood clotting; liver toxicity; and infection.

 

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

 

Gleevec is marketed by East Hanover, N.J.-based Novartis

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