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Keytruda, Opdivo’s Retention Of Hepatocellular Carcinoma Indication May Depend On Ongoing Studies

 
• By Brenda Sandburg

US FDA advisory committee to consider whether new studies can take place of failed confirmatory trials to support accelerated approvals. The agency also wants the panel to consider the changing landscape of HCC following the approval of atezolizumab in combination with bevacizumab.

liver
FDA panel to review liver cancer indications for Keytruda and Opdivo • Source: Alamy

Confirmatory studies to support accelerated approval of Merck & Co., Inc.’s Keytruda (pembrolizumab) and Bristol Myers Squibb Company’s Opdivo (nivolumab) did not demonstrate a clinical benefit for second-line treatment of hepatocellular carcinoma, but the companies may be able to retain the indication at least until additional studies are completed.

At its 29 April meeting, the FDA’s Oncologic Drugs Advisory Committee will consider whether Keytruda and Opdivo can maintain the indication for second-line treatment of hepatocellular carcinoma, the most common type of liver cancer, in

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