FDA advisors endorse minimal residual disease (MRD) as accelerated approval endpoint for multiple myeloma


Last week, FDA’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously in favor of using minimal residual disease (MRD) as an accelerated approval endpoint for multiple myeloma. Committee discussions noted the potential for earlier readout and faster completion of studies, with an expectation that the FDA will ultimately require follow-through with confirmatory trials.

Myeloma is a blood cancer in which B cells, a type of immune cell, overproduce plasma cells. These plasma cells crowd out other types of blood cells in the bone marrow.

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