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1993.03.02 : ; Hairy Cell Leukemia -- Cladribine
 
Contact: Susan Cruzan--301-443-3285 (Home) -- 301-926-7081
March 2, 1993

   The Food and Drug Administration 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 in early l992, 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.
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