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

 
• By Bridget Silverman

The US FDA’s Oncologic Drugs Advisory Committee unanimously agreed that accelerated approvals should be enabled by multiple myeloma trials using MRD as a surrogate endpoint.

ODAC meeting
ODAC members gathered in person for the 12 April meeting, but the public, press and open public hearing speakers participated virtually. • Source: Screenshot

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

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