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 based on clinical trial data measuring MRD. MRD is approved as an intermediate endpoint.
Following the FDA decision, MPE spoke to Dr Bruno Paiva, Director of Flow Cytometry and Director of the Monoclonal Gammopathies Research Laboratory, University of Navarra, Spain. Given his involvement in ODAC meeting and the I2TEAMM project, he commented:
“I welcome the news from the US FDA, as it marks the culmination of years of international effort on behalf of the myeloma community. It remains to be seen what the impact of this FDA decision will be for Europe. Until now, EMA has been generally cautious about the use of MRD as a surrogate endpoint in the applications for myeloma drugs. But the unanimous decision of the FDA Committee to approve MRD as an intermediate endpoint for accelerated approval could signal a renewed interest in MRD as a useful tool in regulatory approvals.”
In this patient Q&A article, we explore why the FDA made the decision and what it means for myeloma patients living in Europe.