Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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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.
Citing changing therapeutic landscape and doubts about utility of checkpoint inhibitor monotherapy in this setting, advisory committee votes 6-2 against maintaining PD-1 inhibitor’s accelerated approval for third-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma.