September 2, 2021

Bristol Myers Squibb has voluntarily withdrawn an indication for Opdivo® (nivolumab) to be used as a single agent to treat patients who have hepatocellular carcinoma (HCC) and were previously treated with sorafenib. Opdivo was granted accelerated approval for the indication in 2017 but failed to meet an overall survival endpoint in a confirmatory trial.

Opdivo still holds FDA approval to treat HCC, the most common form of liver cancer, when used in combination with Yervoy® (ipilimumab – Bristol Myers Squibb). Patients are often diagnosed with HCC when it is already in advanced stages, leaving them with limited treatment options. The five-year survival rate for advanced HCC is less than 15% with first-line standard of care.

First FDA approved in 2014, Opdivo is also indicated for use alone or in combination with other therapies to treat a wide range of cancers including lung, kidney, and skin cancers.

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Opdivo Loses Indication as Single-Agent Treatment for Liver Cancer

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