The US Food and Drug Administration is seeking external input on whether GSK plc’s proposed clinical development program for Jemperli (dostarlimab) in rectal cancer will generate adequate data to support accelerated approval and subsequent confirmation of the drug’s clinical benefit in this setting.
In a briefing document released ahead of a 9 February Oncologic Drugs Advisory Committee meeting, the agency raises a host of concerns about what would be a precedent-setting development...
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