FDA has approved fludarabine, an "orphan" drug that offers people with the most common form of adult leukemia--chronic lymphocytic leukemia, or CLL-an improved quality of life and somewhat longer survival rates.
In clinical trials sponsored by the National Cancer Institute, fludarabine treatment resulted in improvement in 32 to 48 percent of patients, including complete remission in 13 percent. The current treatment of chlorambucil and related alkylating-type chemotherapy, usually with prednisone, is not curative and may be associated with significant side effects. After a certain period, many patients stop responding to the treatment. Fludarabine is approved for people who do not respond to other therapies.
CLL-a slow progressing but usually fatal cancer--is characterized by a buildup of abnormal white blood cells in the bone marrow, blood, liver, spleen, lymph nodes, and other organs. The abnormal cells eventually crowd out normal white and red blood cells and platelets. This form of leukemia is most common in persons over 50 and affects about 8,000 Americans.
Researchers believe that fludarabine inhibits the reproduction of abnormal cells that affect the body's lymph system and associated organs. The drug is administered intravenously, usually on an out-patient basis. The most common side effects associated with the new therapy are bone marrow suppression, fever, chills, infections, nausea, and fatigue.
Fludarabine has been available for a year to many patients under programs of FDA and the National Cancer Institute that permit early use of a possibly effective drug for patients with life-threatening or serious diseases. Because fludarabine was developed for a rare or serious disease affecting relatively few people, FDA designated it as an orphan drug, and thus permitted the drug's sponsor economic incentives to carry out its clinical trials and product development. Fludarabine was approved by FDA 17 months after submission of the new drug application.
The drug is marketed by Berlex Laboratories of Alameda, Calif., and will be sold under the trade name Fludara.
COPYRIGHT 1991 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group
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