GSK’s Phase II, Single-Arm Trial For Jemperli In Rectal Cancer Gets Panel Nod

 
• By Sue Sutter

Oncologic Drugs Advisory Committee members generally agreed with GSK that a randomized study in dMMR/MSI-H patients would not be feasible; despite the favorable vote, panelists still raised concerns about use of 12-month clinical complete response as the primary endpoint.

Plane taking off
GSK's plan for accelerated approval based on single-arm studies was cleared for takeoff by ODAC. • Source: Shutterstock

More from US FDA Performance Tracker

More from Regulatory Trackers