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# BMS Pulls Opdivo Indication for Liver Cancer
- URL: https://www.fdaweb.com/bms-pulls-opdivo-indication-for-liver-cancer/
- Published: 2021-07-26T12:00:00.000Z
- Updated: 2026-09-14T17:07:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149786

Bristol Myers Squibb has voluntarily withdrawn an indication for Opdivo (nivolumab) as a single agent for patients with hepatocellular carcinoma (HCC) who were previously treated with sorafenib. The withdrawal is in response to an FDA industry-wide evaluation of accelerated approvals for checkpoint inhibitors that have not met their post-marketing requirements to demonstratd clinical benefit in a confirmatory study ([see story](https://www.fdaweb.com/genentech-withdraws-tecentriq-for-urothelial-carcinoma/)).  
  
Opdivo was granted accelerated approved for this indication in 2017\. However, CheckMate-459, a confirmatory randomized study of Opdivo versus sorafenib in the first-line setting, did not achieve statistical significance for its primary endpoint of overall survival per a pre-specified analysis, the company says.  

Combination use of Opdivp and the company’s Yervoy (ipilimumab) continues to be approved for use in this patient setting, Bristol-Myers Squibb says.