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IMW 2021 | MRD in myeloma: the FDA perspective

Hermann Einsele, MD, FRCP, of the University of Würzburg, Würzburg, Germany, and Heinz Ludwig, MD, of the Wilhelminen Cancer Research Institute, Wilhelminenspital, Vienna, Austria, discuss measurable residual disease (MRD) assessment for the treatment of myeloma, talking on the perspective of the US Food and Drug Administration (FDA). Prof. Ludwig explains that there are still concerns from the regulatory authorities in regards to the use of MRD as a surrogate marker for survival; however, he believes it is only a question of time until the FDA will fully recognise the strengths of MRD assessment. This interview took place during the 18th International Myeloma Workshop (IMW 2021) congress.


Heinz Ludwig, MD, has received research funding from Amgen and Takeda; and has received speaker’s honoraria and has participated in advisory boards for Amgen, Takeda, Sanofi, Janssen, Celgene-BMS and Seattle Genetics.

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