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                                      author：explore   
                                        
                                      
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browse：165
                                  
                                    
          
                                    
            
          
 
          Amgen HQ
          Mark J. Terrill/AP
          Amid the stunning rebuke Amgen suffered at the hands of the U.S. Food and Drug Administration this week lurk numerous questions. And one of them may be whether the company was fully forthcoming about a pricey lung cancer drug that is supposed to generate key revenue growth.
          At issue is a trial that Amgen is relying upon to win final approval for Lumakras, which the FDA approved on a conditional basis in 2021. This process, known as accelerated approval, required the company to run a confirmatory study. But ahead of an advisory panel meeting on Thursday, the agency released documents showing its staff found “potential systemic bias” in the trial.
          advertisement
          The disclosure throws into question the future of this drug, which has offered hope to patients for whom an effective treatment previously seemed out of reach. Some Wall Street analysts are now betting the FDA will ask Amgen to run yet another trial or maybe withdraw the drug altogether. Either way, the prognosticators are reworking their calculus for Amgen stock.
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