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FDA Approves New Childhood Leukemia Treatment

From Associated Press (November 18, 2011)

WASHINGTON -- The Food and Drug Administration has approved a new chemotherapy designed to treat childhood leukemia patients who are allergic to standard treatments.

The FDA said Friday it approved Erwinaze as a treatment for patients with acute lymphoblastic leukemia. The drug is made by the privately held EUSA Pharma, headquartered in the United Kingdom and has operations in the United States.

EUSA Pharma said acute lymphoblastic leukemia is the most common form of childhood cancer and one of the most curable types. But 15 percent to 20 percent of patients, or between 450 to 600 children in the United States each year, are unable to take standard chemotherapies.

Acute lymphoblastic leukemia is a form of cancer in which the bone marrow makes too many lymphocytes, a type of white blood cell. Erwinaze is injected into muscle and breaks down one of the body's protein building blocks, the FDA said. This causes the leukemia cells to die, but it leaves normal cells unaffected.

Erwinaze has orphan drug status, which is given to drugs for rare illnesses or diseases for which there is no treatment. It comes with incentives and includes marketing exclusivity if the product is approved.


Posted: November 2011