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EMA Gives Advice On Biomarker That Could Speed Up AML Drug Development

Traditional Clinical Endpoint Of Survival Has Made Acute Myeloid Leukemia Trials Lengthy

 
• By Vibha Sharma

The European Medicines Agency has issued a “letter of support” to encourage ongoing efforts by an industry-led consortium to establish measurable residual disease as a surrogate efficacy endpoint in clinical studies of patients with acute myeloid leukemia. 

Acute Myeloid Leukemia word, medical term word with medical concepts in blackboard and medical equipment.
AML Patients That Test MRD Negative Have Been Associated With Better Survival • Source: Shutterstock

The European Medicines Agency has given its backing to an initiative that is seeking to establish measurable residual disease (MRD) as a surrogate efficacy endpoint in clinical trials of patients with acute myeloid leukemia (AML) and has explained what data are needed to do so.

The agency has written a “letter of support" to a consortium that is working to establish MRD as a surrogate endpoint for overall survival in trials of drugs for...

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