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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Keeping Track: US FDA Approval Of Jazz Rylaze Addresses Shortage; MediWound, Cyclopharm Receive CRLs
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
While Opdivo’s first-line approval has altered the treatment landscape, Keytruda may expand its presence there in the next few years with new indications.
Contract research organization leaders weigh in on how to avoid some recent pitfalls seen at US FDA advisory committee panels.