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.

Sun and clouds
The gastric cancer treatment landscape has brightened, putting a cloud over Keytruda’s accelerated approval for third-line use. • Source: Alamy

More from US FDA Performance Tracker

More from Regulatory Trackers