MRD Tests May Speed Myeloma Tx Approvals

A panel of US government advisers unanimously supported the use of highly sensitive tests to detect minimal residual disease in multiple myeloma patients to speed up drug approvals. The FDA is not required to follow this recommendation but often does. Panelists emphasized the importance of confirmatory studies to validate findings based on MRD data. Researchers are working to address concerns about the potential for misleading results and the need for new treatments for multiple myeloma. The FDA has approved multiple new drugs for this disease in recent years. However, there are still challenges in using MRD as an endpoint in clinical trials.

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