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Minimal Residual Disease Inches Closer To Supporting Myeloma Accelerated Approvals

 
• By Bridget Silverman

US FDA’s oncology advisory committee will discuss two meta-analyses supporting use of MRD as a surrogate endpoint to support accelerated approval in multiple myeloma trials.

multiple myeloma
• Source: Shutterstock

The decade-long quest to qualify minimal residual disease (MRD) as a surrogate endpoint in multiple myeloma trials could inch closer to its use to support accelerated approvals, depending on the outcome of the 12 April 2024 meeting of the US FDA’s Oncologic Drugs Advisory Committee.

Key Takeaways

  • FDA’s Oncologic Drugs Advisory Committee will vote on 12 April to determine if evidence supports the use of minimal residual disease (MRD) as an accelerated approval endpoint in multiple myeloma clinical trials.

  • The panel will discuss meta-analyses conducted by the University of Miami and the International Independent Team for Endpoint Approval of Myeloma Minimal Residual Disease

The ODAC will take a break from specific product-focused reviews with a session targeting a single voting question: “Does the evidence support the use of MRD as

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