ASH and the Food and Drug Administration are cosponsoring two public workshops that will provide a forum for discussion of extending the qualification of minimal residual disease (MRD) detection as a prognostic biomarker to that of an efficacy/response biomarker in evaluating new drugs for the treatment of chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML). The CLL Workshop is scheduled for February 27, 2013 and the AML Workshop is scheduled for March 4, 2013. The goal of the Workshops is to provide a venue for an in-depth discussion of potential surrogate endpoints for trials intended to support the approval of new drugs or biologics. The Workshops will be held at the FDA White Oak Campus in Silver Spring, MD, and advance registration is recommended: register for the CLL Workshop and/or register for the AML Workshop.
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