An FDA advisory committee unanimously voted minimal residual disease should be an accepted endpoint for accelerated approval of clinical trials investigating treatments for patients with multiple myeloma.
PFS and OS are the current endpoints in multiple myeloma trials, but the committee believed the data presented, which encompassed numerous trials, proved minimal residual disease (MRD) had a strong association with PFS and could be acted upon much earlier.
“I’ve actually never before seen this level of data presented on simply moving the bar on response,” Jorge J. Nieva, MD,
