Keytruda's Third-Line Gastric Cancer Indication Should Go, US FDA Panel Says
Executive Summary
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.
You may also be interested in...
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
After ODAC: The State Of Accelerated Approval At The US FDA
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’s Keytruda: The ‘Wall Of Data’ Still Holds After ODAC Look Back
Merck has pulled one Accelerated Approval indication for Keytruda already this year, and a second may have to be withdrawn as well.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.