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Bristol Myers Pulls Accelerated Approval For Opdivo In Post-Nexavar Liver Cancer

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Bristol Myers Pulls Accelerated Approval For Opdivo In Post-Nexavar Liver Cancer
  • Bristol Myers Squibb & Co (NYSE: BMY) on Friday said it's voluntarily withdrawing Opdivo's approval in hepatocellular carcinoma (HCC) patients who previously received Bayer AG's (OTC: BAYRY) standard-of-care Nexavar.
  • The decision came about three months after an independent FDA advisory committee voted 5-4 to remove the Opdivo accelerated approval, which the company scored back in 2017 based on tumor shrinkage data. 
  • For Opdivo, concerns about its use in second-line liver cancer use cropped up after the drug failed a confirmatory trial in the first-line setting. 
  • In the CheckMate-459 trial, the PD-1 inhibitor failed to significantly prolong the time newly diagnosed liver cancer patients lived compared with Nexavar.
  • While Bristol Myers says it has additional trials in the works for the use of Opdivo as a monotherapy and in combination with Yervoy "across different disease settings," the company said on Friday that it's also pursuing "new therapeutic approaches" for patients with HCC.
  • Price Action: BMY shares are down 0.90% at $67.73 during the market session on the last check Monday.
  • Related content: Benzinga's Full FDA Calendar.
 

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Posted-In: Briefs Liver CancerBiotech News Health Care FDA General

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