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.