Minimal Residual Disease Gains Max US FDA AdComm Support For Myeloma Trials

The Consolidated Appropriations Act of 2023 was a star of the US Food and Drug Administration’s Oncologic Drugs Advisory Committee 12 April meeting, where the agency’s expanded accelerated approval withdrawal authority was repeatedly cited as a crucial backstop that reduced the risk associated with a new surrogate endpoint based on minimal residual disease in multiple myeloma.

ODAC voted unanimously in favor of minimal residual disease (MRD) as a novel endpoint to support accelerated approval of multiple myeloma therapies after considering meta-analyses coordinated by the University of Miami and the International Independent Team for Endpoint Approval of Myeloma Minimal Residual Disease (i2TEAMM), as well as the FDA’s own meta-analyses