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FDA Panel Narrowly Votes Against Opdivo’s Liver Cancer Indication

By Beth Wang / April 30, 2021 at 3:18 PM
FDA’s oncology advisory committee on Thursday (April 29) narrowly voted against letting Bristol-Myers Squibb’s Opdivo (nivolumab) maintain its accelerated approval as a second-line treatment for patients with a type of liver cancer known as hepatocellular carcinoma. At the same time, the committee unanimously agreed to let Merck Sharpe & Dohme keep its drug, Keytruda (pembrolizumab), on the market for the same indication. Keytruda and Opdivo are among three programmed cell death 1 (PD-1) and programmed cell death ligand 1 (PD-L1)...


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