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.
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GSK’s Phase II, Single-Arm Trial For Jemperli In Rectal Cancer Gets Panel Nod
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.
GSK’s Clinical Development Plan For Jemperli In Rectal Cancer Draws US FDA Concerns
Oncologic Drugs Advisory Committee asked to weigh in on adequacy of GSK’s proposal for two single-arm trials to support accelerated approval in a curative setting, as well as the potential novel use of clinical complete response as an approval endpoint.
Inside US FDA’s Return To In-Person Meetings
In an interview, OND Deputy Director of Operations Kevin Bugin describes how FDA might be able to "accelerate" the transition back to in-person meetings if the initial phase with Type A and BPD Type 1 meetings goes well. But there is still no plan to return to in-person advisory committees.