News
Opdivo indication for hepatocellular carcinoma (liver cancer) withdrawn from FDA.- BMS
The company 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.
Opdivo has been withdrawn earlier for this indication in Europe .
Condition: Liver Cancer
Type: drug