Answers
03/02/1993

<TITLE>ONE-TREATMENT INTRAVENOUS DRUG FOR HAIRY CELL LEUKEMIA</TITLE>
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P93-7                                           Food and Drug Administration
FOR IMMEDIATE RELEASE                           Susan Cruzan--301-443-3285
March 2, 1993                                   (Home) -- 301-926-7081

ONE-TREATMENT INTRAVENOUS DRUG FOR HAIRY CELL LEUKEMIA

   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, 
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                                                   Page 2, P93-7, Cladribine
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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