iwMyeloma 2024 | MRD as an endpoint for accelerating drug approval in multiple myeloma: updates from the ODAC meeting

On 12th April 2024, a meeting of the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) was held to assess the use of measurable residual disease (MRD) as a regulatory endpoint to accelerate the approval of novel therapies in multiple myeloma (MM). Ola Landgren, MD, PhD, Sylvester Comprehensive Cancer Center, Miami, FL, shares an insight into the meeting, during which his team from the Sylvester Comprehensive Cancer Center, the i2TEAMM, and the FDA gave three presentations on data supporting the use of MRD as a surrogate endpoint. Following this, all 12 ODAC members present voted ‘for’ the use of MRD as ‘an endpoint reasonably likely to predict clinical benefit’. Prof. Landgren highlights that this is a milestone in the field of myeloma and will accelerate the drug approval process by a factor of two to three, saving many years of patients’ lives and allowing for the development of curative therapies. This interview took place at the 17th International Workshop on Myeloma (iwMyeloma) in Miami, FL.

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