Posted by Michael Wonder on 26 Jul 2021
Bristol Myers Squibb statement on Opdivo (nivolumab) monotherapy post sorafenib hepatocellular carcinoma U.S. indication
23 July 2021 - In consultation with the U.S. FDA, Bristol Myers Squibb has made the difficult decision to voluntarily withdraw the indication for Opdivo (nivolumab) as a single agent for patients with hepatocellular carcinoma who were previously treated with sorafenib from the U.S. market.
BMS took this action following the Agency’s industry wide evaluation of accelerated approvals for checkpoint inhibitors that have not met their post-marketing requirements demonstrating confirmatory benefit.
This included a meeting of the Oncologic Drugs Advisory Committee in April and subsequent discussion with the FDA.
