Q&A: US Food and Drug Administration (FDA) approves MRD as a basis for accelerated approval in myeloma

  Last Friday, the US FDA’s Oncology Drugs Advisory Committee (ODAC) (FDA being the US medicines regulator) voted 12 – 0 to approve minimal residual disease (MRD) as an accepted endpoint for accelerated approval of new myeloma drugs. The committee’s primary role is to review benefit-risk data of new cancer drugs. You can see the full meeting and evidence considered here. The decision means that myeloma drugs may now be approved earlier in the US…