Bristol Myers Squibb withdraws liver cancer indication for nivolumab

Bristol Myers Squibb withdraws liver cancer indication for nivolumab

Bristol Myers Squibb in consultation with the FDA voluntarily withdrew the indication for nivolumab as monotherapy for patients with hepatocellular carcinoma previously treated with sorafenib.The company did so after the agency’s evaluation of accelerated approvals for checkpoint inhibitors that did not meet post-marketing requirements.The evaluation process included a special Oncologic Drugs Advisory Committee (ODAC) meeting this spring, as well as follow-up discussion with the FDA. ODAC members voted 5-4 against maintaining the nivolumab indication.“We are disappointed by theRead More

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