BMS Pulls Opdivo Indication for Liver Cancer

Bristol Myers Squibb has voluntarily withdrawn an indication for Opdivo (nivolumab) as a single agent for patients with hepatocellular carcinoma (HCC) who were previously treated with sorafenib.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).

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.