FDA Will Revisit Appropriate Use Of PFS Endpoints At Advisory Committee
This article was originally published in The Pink Sheet Daily
Executive SummaryFDA's Pazdur says the time has come for an Oncologic Drugs Advisory Committee meeting devoted to issues surrounding use of progression-free survival endpoints - including clinical relevance.
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The Oncologic Drugs Advisory Committee’s July 24 meeting to discuss the merits of independent radiological review of progression assessments in a pre-specified subgroup of patients, instead of 100% of all assessments, comes three years after the agency signaled it was open to considering such an approach.