FDA ADVISORY COMMITTEE RECOMMENDS TAXOL FOR OVARIAN CANCER

NEWS 11/18/1992 FDA ADVISORY COMMITTEE RECOMMENDS TAXOL FOR OVARIAN CANCER

T92-56                                                Susan Cruzan
Nov. 18, 1992                                         (301) 443-3285

         FDA ADVISORY COMMITTEE RECOMMENDS TAXOL FOR OVARIAN CANCER 
    We have had some media interest concerning the Nov. 16 recommendation by  
the FDA Oncology Drugs Advisory Committee that Taxol (paclitaxel) be          
approved for treatment of refractory ovarian cancer (cancer that is           
unresponsive to conventional therapy).  
    The committee, a group of outside experts, considered data presented by   
representatives of FDA, the National Cancer Institute (NCI) and               
Bristol-Myers Squibb Co., manufacturer of Taxol.  The committee's             
recommendations were based on its conclusion that the data showed evidence    
of Taxol's effectiveness that is strong enough to allow its use in patients   
who have failed first line chemotherapy.
    Clinical trials conducted by NCI at five centers around the country,      
plus multi-center trials in Europe sponsored by the manufacturer, were        
reported to have confirmed that Taxol shrinks tumors by at least one-half in  
20 to 30 percent of patients with refractory ovarian cancer, for an average   
of five months.  In these studies Taxol, like many other cancer drugs, was    
associated with serious side effects including a decrease in white blood      
cells (which may cause susceptibility to infections), hair loss and numbness  
of the fingers and toes.
    FDA has completed its initial review of information on Taxol, 
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the agency is awaiting further data relating to manufacture of the drug and   
completion of an environmental assessment, required by law.  Because taxol    
is obtained from the Pacific yew tree, this involves an assessment of the     
effect of yew harvesting on U.S. forests.  The environmental assessment is    
being prepared in cooperation with the U.S. Forest Service.
    NCI and Bristol-Myers Squibb are also working under a collaborative       
agreement to find new sources of the active ingredient and to further         
develop Taxol as an anti-cancer drug.  
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