Bristol-Myers Squibb Co.’s (BMY) Opdivo, which won accelerated approval as a single agent for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with Sorafenib, in September 2017, faces the FDA panel on April 29, 2021.The accelerated approval was based on results of a phase I/II trial, dubbed CheckMate-040, in which the overall response rate was 18.2% for patients who had previously been treated with Bayer’s Sorafenib.However, a phase III trial comparing Opdivo against Sorafenib in liver cancer, dubbed CheckMate -459, whose results were reported in June 2019, had failed to meet statistical significance for overall survival.The FDA panel will discuss the next steps forward for Opdivo in this particular indication.BMY closed Friday’s (Mar.26, 2021) trading at $63.94, up 1.83%.