FDA's ODAC Recognizes MRD as an Accepted End Point ...
The FDA's Oncologic Drugs Advisory Committee unanimously supported minimal residual disease (MRD) as an endpoint for accelerated approval of multiple myeloma treatments, acknowledging its prognostic value for progression-free and overall survival. However, concerns were raised about MRD's limitations and the need for FDA vigilance to ensure long-term clinical efficacy.
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The FDA's Oncologic Drugs Advisory Committee unanimously supported minimal residual disease (MRD) as an endpoint for accelerated approval of multiple myeloma treatments, acknowledging its prognostic value for progression-free and overall survival. However, concerns were raised about MRD's limitations and the need for FDA vigilance to ensure long-term clinical efficacy.
FDA's Oncologic Drugs Advisory Committee to evaluate MRD as an endpoint in multiple myeloma trials.