In consultation with the FDA, Bristol Myers Squibb (BMS) has voluntarily withdrawn from the U.S. market the indication for nivolumab (Opdivo) as monotherapy for hepatocellular carcinoma (HCC) after sorafenib.
The company reported that it took this action after the FDA’s industry-wide evaluation of accelerated approvals for checkpoint inhibitors that have not met their postmarketing requirements for confirming benefit. This included a meeting of the Oncologic Drugs Advisory Committee in