Posted by Michael Wonder on 09 Apr 2019
Minimal residual disease as a surrogate outcome for product development for multiple myeloma: comparing FDA and EMA guidances
8 April 2019 - This article discusses the need to update regulatory science to include the use of minimal residual disease as a specific measure of tumour burden for multiple myeloma at levels undetectable through conventional laboratory techniques.
The authors suggest minimal residual disease (MRD) can potentially be used as a clinical and regulatory endpoint to evaluate a drug’s effect both on patients’ risk of future relapse risk and subsequent treatment survival outcomes, thus serving as a surrogate endpoint for early drug approvals for patients with multiple myeloma.
The authors review and compare FDA and EMA guidances and advocate for flexible regulatory approaches to data requirements for the use of MRD.
