Keytruda's Third-Line Gastric Cancer Indication Should Go, US FDA Panel Says

30 Apr 2021

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

A US Food and Drug Administration advisory committee recommended withdrawing accelerated approval of Merck & Co., Inc.’s Keytruda (pembrolizumab) in third-line gastrointestinal cancer, citing the changing treatment landscape resulting from a recent front-line immunotherapy approval and doubts about the utility of checkpoint inhibitor monotherapy in this cancer.

In favoring withdrawal, members of the Oncologic Drugs Advisory Committee said the recent approval of Bristol Myers Squibb Company’s...