GSK’s Phase II, Single-Arm Trial For Jemperli In Rectal Cancer Gets Panel Nod
Executive Summary
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.
You may also be interested in...
US FDA Advisory Committees' Future: Drug-Agnostic Panels, More Debate Time
FDA Commissioner Califf and some top deputies are angling for more advisory panels that would influence drug development programs rather than approval decisions. Califf also wants to adjust meeting formats so advisors have more time for in-depth discussions.
US FDA Advisory Committees' Future: Drug-Agnostic Panels, More Debate Time
FDA Commissioner Califf and some top deputies are angling for more advisory panels that would influence drug development programs rather than approval decisions. Califf also wants to adjust meeting formats so advisors have more time for in-depth discussions.
GSK Ends Pact with Vir For New COVID Treatments
Its Xevudy partner GSK is pulling out but Vir is going to carry on looking for new COVID-19 solutions independently, or with other partners.