<code id='661B386680'></code><style id='661B386680'></style>
      • <acronym id='661B386680'></acronym>
      <center id='661B386680'><center id='661B386680'><tfoot id='661B386680'></tfoot></center><abbr id='661B386680'><dir id='661B386680'><tfoot id='661B386680'></tfoot><noframes id='661B386680'>
      • <optgroup id='661B386680'><strike id='661B386680'><sup id='661B386680'></sup></strike><code id='661B386680'></code></optgroup>
        5. <b id='661B386680'><label id='661B386680'><select id='661B386680'><dt id='661B386680'><span id='661B386680'></span></dt></select></label></b><u id='661B386680'></u>
          <i id='661B386680'><strike id='661B386680'><tt id='661B386680'><pre id='661B386680'></pre></tt></strike></i>
           


   

   

   
   
   
   
   
   
   
   
   
   
   
   
   

   
   
   
   
   
   
   
  
           
  
           
  
           
   
           
    
           
     
           
      
           
       
      
           
      
           
       
           
        
           
         
           
           
          
           
         
           
         
           
           
          
           
         
           
          
        
           
       
           
       
           
        
           
        
           
        
           
        
           
       
           
      
           
       
      
           
      
           
       
           
       
           
       
           
       
           
        
           
        
          
          00:00 
        
           
       
           
       
           
      
           
      
           
        
        
        
       
           
        00:00 
         
        00:00 
        LIVE 
       
           
        
       
           
        
           
        
           
        
           
        
           
       
           
       
           
       
           
        
        
        
        
        
        
        
        
        
      
           
       
    
    
      
           
       
           
      
           
     
           
     
           
       
     
           
     
           
      
           
      
           
      
           
      
           
       
           
      
           
      
           
      
           
       
           
       
          
         buffering 
       
           
      
           
      
           
       
           
        
           
        
          
          Replay 
        
           
       
           
      
           
       
      
           
      
           
       
           
       
           
        
           
        
           
        
           
       
           
      
           
      
           
      
           
      
           
      
           
       
           
      
           
     
           
     
           
      
           
     
           
     
           
      
           
       
           
        
           
       
           
       
           
        
          
          LIVE 
        
           
        00:00 
         /  
        00:00 
       
           
       
           
        
           
        
           
        
           
         
           
         
           
         
           
         
           
         
           
         
           
        
           
        
           
        
           
       
           
       
           
        
           
        
          
          LIVE 
        
           
       
           
       
           
        
           
        
          
          CC 
        
           
       
           
       
           
        
           
       
           
       
           
       
           
        
           
        
           
         
           
        
           
       
           
       
           
        
           
       
           
      
           
      
           
       
           
        
           
        
           
         
           
         
           
         
           
          
           
          
           
          
           
         
           
        
           
       
           
      
           
      
           
       
           
     
       
           
    
       
           
       
    
  
       
           
   
       
           
       
       
           
      
           
      
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       
           
       Opacity : 
        
      
           
     
           
     
           
     
           
      
           
  
     
           
    
           
    
           
    
           
     
          
       Share: 
     
           
      
     
           
      
      Copy 
     
           
      
    
           
    
          
      Close 
      
    
           
    
           
      
    
           
    
           
   
           
  
           
  
           
    
    
    
   
           
   
           
 
    
   
           
   
           
   
           
    
           
     
           
      
           
       
           
        
           
          
          
         
          
          Wikipedia 

          
          
            
          
          

           
           
        
           
       
           
      
           
     
           
    
           
    
           
     
           
      
           
      
           

                       
          knowledge  
          
                                   
                 
                                      author：knowledge   
                                        
                                      
                                      -
 
browse：885
                                  
                                    
          
                                    
            
          
 
          Richard Pazdur
          Richard Pazdur, right, also spoke about the FDA's use of accelerated approval. 																									Megan Bearder Photography
          CHICAGO — The Food and Drug Administration’s top oncologist reiterated that the agency doesn’t want drugmakers applying for approval with data from trials solely run in a single country such as China, but instead wants to see companies conducting studies across the world.
          The comments by Richard Pazdur, director of the FDA’s Oncology Center of Excellence, came as more drugmakers report data from China, with Miami-based Summit Therapeutics earlier this week announcing that its investigational drug beat Merck’s blockbuster Keytruda in a head-to-head non-small cell lung cancer study in China.
          advertisement
          It’s not a blanket policy, and the agency would assess each company’s submission to see how applicable the data are to the U.S. population, but in general, “I am pro multi-regional trials,” Pazdur said Friday at STAT@ASCO, STAT’s event at the American Society of Clinical Oncology annual meeting.
          STAT+ Exclusive Story
          Already have an account? Log in
          STAT+
          This article is exclusive to STAT+ subscribers
          Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+.
          Already have an account? Log in
          Already have an account? Log in
          Monthly
          $39
          Totals $468 per year
          $39/month			Get Started			
          Totals $468 per year
          Starter
          $30
          for 3 months, then $39/month
          $30 for 3 months			Get Started			
          Then $39/month
          Annual
          $399
          Save 15%
          $399/year			Get Started			
          Save 15%
          11+ Users
          Custom
          Savings start at 25%!
          Request A Quote			Request A Quote			
          Savings start at 25%!
          2-10 Users
          $300
          Annually per user
          $300/year			Get Started			
          $300 Annually per user
          View All Plans																															
          Get unlimited access to award-winning journalism and exclusive events.					
          Subscribe																						Log In															
           
 
 
          

                              
          
                                 Previous article：

                                
                                          Walensky prepares to leave CDC — and Congress — behind
                                
                            
          Next article：  
                                      
                                          DeSantis can now import cheaper drugs. But will Biden get credit?
                                                                    
          

      
           
      
           
        
           
                                               
        
           Wikipedia 
           
                   
      
           
  
  
          
    
          
        
          
            
          
                                                     
                
          hotspot
          
                            
          
        
          
        
    
          

          

    

      
           
     
           


   
    
           
   
           
  
 

  
           
    
           
           
           
            
            Back To Top 
           
           
           
           

            
           
                                                                    
                 
          entertainment
           
                                      
            
           
          
           
                                                          
             
          entertainment
           
                             
            
           
            
           

                                                         
             
          hotspot
           
               
              
            
           
            
           
                                                         
             
          Wikipedia
           
                             
      
           
 
     
           
     
           
      
          
              ChristineKao/STATResearchersattendinggenetherapymeetingsoverthepastcoupleyearswereliabletobumpintoas
             
           
      
          
        © 2013-2023.Company name All rights reserved.Site Map 
         WSS-More Templates  
             Guangdong ICP45936name