FDA assembles adcomm to review GSK's Jemperli trial plans in rectal cancer
The FDA’s Oncologic Drugs Advisory Committee will meet this Thursday to discuss whether proposed studies would support an accelerated approval for GSK’s Jemperli in rectal cancer — despite initial concerns about the trial plans.
GSK’s PD-1 blocker Jemperli, also known as dostarlimab, was first approved back in 2021 for a specific subset of recurrent or advanced endometrial cancer patients who have a genetic feature called dMMR, or deficient mismatch repair. The label was expanded months later to include all adults with dMMR recurrent or advanced solid tumors who have progressed or stagnated on earlier therapy.
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