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FDA Panel Okays Keytruda’s Hepatocellular Carcinoma Indication, But Splits On Opdivo

 
• By Brenda Sandburg

In 5-4 vote, US FDA advisory committee recommends withdrawal of Opdivo’s accelerated approval for second-line treatment of HCC while unanimously supporting the indication in Keytruda pending outcome of ongoing studies.

Opposite results
FDA advisory panel reaches opposite conclusions on Keytruda, Opdivo HCC indication • Source: Alamy

A US Food and Drug Administration panel reached starkly different conclusions on whether Merck & Co., Inc.’s Keytruda (pembrolizumab) and Bristol Myers Squibb Company’s Opdivo (nivolumab) should retain accelerated approval indications for second-line treatment of hepatocellular carcinoma.

At its 29 April meeting, the Oncologic Drugs Advisory Committee unanimously voted in favor of Keytruda keeping the indication pending the outcome of ongoing studies while voting 5-4 against Opdivo’s maintaining the indication

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