FDA Advisory Committee Unanimously Approves MRD as Endpoint for Myeloma Trials
TL;DR Summary
The FDA's Oncologic Drugs Advisory Committee voted 12 to 0 in favor of using minimal residual disease (MRD) as an accelerated approval endpoint in multiple myeloma clinical trials. This decision could potentially lead to earlier access to effective treatments for patients and the possibility of stopping therapy based on MRD. The use of MRD as an endpoint in different myeloma disease settings and the acceptability of time points for MRD assessment were also discussed during the meeting.
Topics:business#clinical-trials#fda#healthcare#minimal-residual-disease#multiple-myeloma#oncologic-drugs-advisory-committee
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