FDA Panel Okays Keytruda’s Hepatocellular Carcinoma Indication, But Splits On Opdivo
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.
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Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
US FDA’s Accelerated Approval process has always been a deceptively simple idea. After a three-day public review of ‘dangling’ applications, the underlying complexity remains.
Merck has pulled one Accelerated Approval indication for Keytruda already this year, and a second may have to be withdrawn as well. That will leave the product with 27 indications in the US – unless, of course, more are approved before the AA indications are formally pulled.