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LEUSTATIN APPROVED FOR HAIRY CELL LEUKEMIA

 WASHINGTON, March 2 /PRNewswire/ -- The Food and Drug Administration (FDA) today announced approval of a one-treatment intravenous drug for hairy cell leukemia, a rare, often fatal cancer of the blood and bone marrow.
 The drug, cladribine, with the trade name of Leustatin, is given to patients in one continuous treatment over a seven-day period rather than in several separate treatments over a period of months, as required for other cancer drugs. While most cancer drugs act on one specific stage of cell activity, cladribine destroys both dividing cells and cells at rest.
 The U.S. approval is the first in the world.
 "The drug provides an important new option for patients with hairy cell leukemia," said FDA Commissioner David A. Kessler, M.D. "The single treatment required with this drug represents a significant advance."
 In clinical trials, 89 percent of patients treated once with Leustatin experienced either complete or partial remission of their cancer for eight to 25 months. Signs of remission include a return to normal blood and bone marrow counts without disease symptoms such as fatigue, anemia and recurrent infections.
 At present, patient followup is too short to assess the long-term benefits of the drug. For this reason, the company will be following patients who took part in the clinical trials and reporting the results to FDA.
 Because only one treatment is required, patients may not experience some of the recurrent side effects frequently associated with multiple treatments, such as nausea, vomiting, headaches and rashes. The most serious side effects associated with Leustatin include fever and a low white blood cell count during the first two months after treatment.
 Hairy cell leukemia is named for the "hairy" appearance of the cancer cells under the microscope. The disease currently affects about 3,000 patients, mostly men. About 600 new cases occur each year. Due to the low incidence of the disease, Leustatin has been designated as an "orphan" product. This designation provides incentives for companies developing products for rare diseases -- those affecting fewer than 200,000 people in the United States.
 The drug was granted a treatment IND is early 1992, allowing its expanded use prior to approval. It will be marketed by Ortho Biotech, Inc., of Raritan, N.J., an affiliate of Johnson and Johnson.
 FDA is one of the eight Public Health Service agencies within HHS.
 -0- 3/2/93
 /NOTE: TV broadcasters please use open caption for the hearing impaired./
 /CONTACT: Susan Cruzan of the Food and Drug Administration, 301-443-3285 or, after hours, 301-926-7081/


CO: Food and Drug Administration; Ortho Biotech, Inc. ST: District of Columbia IN: MTC SU:

MH -- DC029 -- 1990 03/02/93 13:18 EST
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Date:Mar 2, 1993
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