Keytruda's Third-Line Gastric Cancer Indication Should Go, US FDA Panel Says
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.
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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Merck has pulled one Accelerated Approval indication for Keytruda already this year, and a second may have to be withdrawn as well.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.