News
05/05/1992

<TITLE>License Granted for Aldesleukin for Treatment of Metastic Renal Cell Carcinoma (Kidney Cancer)</TITLE>
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P92-12                                        Food and Drug Administration
FOR IMMEDIATE RELEASE                         Monica Revelle - (301) 443-4177


    The Food and Drug Administration today announced the licensing of a       
genetically engineered product, aldesleukin, for the treatment of metastatic  
renal cell carcinoma (kidney cancer) in adults.
    Aldesleukin is the first FDA-approved drug treatment specifically for     
kidney cancer, a disease which accounts for about 10,000 deaths each year.    
Derived from genetically engineered bacteria that contain an analog of the    
human interleukin-2, aldesleukin is a lymphokine involved in regulating       
immune response.
    While aldesleukin is not a cure and most patients in clinical trials      
experienced serious side effects, the drug will provide some patients a       
treatment alternative.
    "This treatment represents one of the first successful attempts to fight  
cancer by augmenting the function of the body's immune system," said FDA      
Commissioner David A. Kessler, M.D.  "Immunotherapy using aldesleukin is an   
example of the potential for modern biotechnology to improve health care."
    In seven clinical trials involving 21 institutions, 255 patients with     
metastatic renal cell cancer were treated with aldesleukin.  The drug         
reduced the size of tumors in 15 percent of the patients; 4 percent of the    
patients had all evidence of their tumors disappear for about 23 months, and
11 percent reported a substantial reduction in the size of the tumor for      
nearly 19 months.
    However, most of the patients in the clinical trials experienced severe   
side effects, and many experienced life-threatening side effects.  Patients   
usually recovered from side effects after therapy, but in 11 of the 255       
patients (4 percent), drug-related side effects resulted in death.
    The toxicities included capillary leak syndrome--the passing of plasma    
proteins and fluid outside the blood vessels.  Capillary leak syndrome can    
result in hypotension and reduced circulation of blood in the organs, which   
may be severe and can result in death.
    Other serious adverse reactions included cardiac arrhythmias, angina,     
myocardial infarction, respiratory failure, gastrointestinal bleeding,        
kidney failure (requiring dialysis), neurologic problems and infections.      
Most of the adverse reactions were usually reversible within two or three     
days after discontinuing treatment.
    Because of these severe adverse reactions, the agency has labeled 
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                                            Page 2, P92-12, Aldesleukin

aldesleukin to be administered intravenously only in a hospital setting       
under the supervision of a qualified physician experienced in the use of      
anticancer drugs.  An intensive care facility and specialists skilled in      
cardiopulmonary or intensive care medicine must be available.  The labeling   
requirements of this drug also should restrict the treatment to patients      
with normal cardiac and pulmonary functions.
    In 1988, aldesleukin was designated an orphan drug -- a designation       
which provides incentives for manufacturers to develop and produce medical    
products to treat rare diseases and conditions.  On Jan. 17, 1992, the
Biologic Response Modifiers Advisory Committee recommended that the drug be   
approved for metastatic renal cell carcinoma with labeling that alerts        
physicians to the toxic effects associated with its administration.
    Aldesleukin is manufactured by Chiron Corporation of Emeryville, Calif.,  
and will be distributed by Cetus Oncology Corporation under the trade name    
Proleukin.  The product will be commercially available in mid-May.

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