FDA Panel Approves Childhood Leukemia Drug
Federal health advisers on Wednesday recommended approval of the first new cancer drug in the past decade specifically aimed at treating the most common childhood leukemia (search).
The panel, an advisory arm of the Food and Drug Administration, stopped short of recommending approval of Clolar for treatment of another form of leukemia, however, saying more proof was needed of the drug's clinical benefit.
Clolar (search) was approved for treatment of children from age 1 to 21 with refractory or relapsed acute leukemias who have exhausted other treatment options.
Jeffrey Buchalter, president and chief executive officer of Ilex Products Inc., the drug manufacturer, said the federal advisers' decision not to recommend approval of Clolar to treat acute myelogenous leukemia may be subject to change.
"We think this drug has potential," he said. "The issue is they need more data ... that the drug provided a clinical benefit. We've very interested in working with the FDA."
While the FDA is not bound to follow the guidance of its Oncologic Drugs Advisory Committee, the agency typically heeds its federal advisers' recommendations.
About 3,830 new cases of acute lymphocytic leukemia, the most common type of leukemia in children younger than 19, are diagnosed each year in the United States. The disease arises due to genetic injury to the DNA of a single cell in the bone marrow. According to the Leukemia and Lymphoma Society, acute leukemia is a rapidly progressing disease affecting unformed and immature cells.
Ilex is a unit of San Antonio, Texas-based Ilex Oncology, which is being purchased by Cambridge, Mass.-based Genzyme.