Food and Drug Administration Approves Gleevec

prescription bottleThe Food and Drug Administration has approved of the use of a drug called Gleevec for children who have acute lymphoblastic leukemia. It has previously been approved to treat adult patients with several conditions. Gleevec is marketed by Novartis.

On January 25, 2013, the Food and Drug Administration (FDA) approved of the use of a drug called Gleevec for children who have acute lymphoblastic leukemia. Gleevec is also called imatinib. It has been specifically approved to treat kids who have been newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia. (ALL).

ALL is a fast-growing cancer of the white blood cells. It may either be called acute lymphocytic leukemia or acute lymphoid leukemia. The bone marrow of a person who has this form of cancer makes lots of unformed cells called blasts. Those cells would normally develop into lymphocytes, but are abnormal in patients who have ALL.

The abnormal blasts do not develop into lymphocytes and cannot fight infections. They grow in number very quickly, and crowd out the normal red blood cells, white blood cells, and platelets that a person’s body needs. This makes it incredibly difficult for the body to fight off infection.

There are around 4,000 new cases of ALL diagnosed in the United States every year. Most of the patients, around 2,900, are children younger than the age of 10. It is the most common type of leukemia in children.

Gleevec is a tyrosine kinase inhibitor. It blocks the proteins that promote the development of cancerous cells. The drug is intended to be used in combination with chemotherapy to treat children with PH+ALL.

Richard Pazdur, M.D., is the director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. He said:

We are pleased that the number of cancer medications for children are on the rise. 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.

Image by Dawn Mcllvain Stahl on Flickr