FDA to discuss minimal residual disease as surrogate endpoint

The American Society of Clinical Oncology and FDA's Office of Hematology and Oncology Products will jointly hold public workshops to discuss the regulatory, scientific, and clinical basis for using minimal residual disease (MRD) as a surrogate endpoint in pivotal trials for a group of hematological malignancies. The groups will meet on Feb. 27, 2013, to discuss MRD as a surrogate response or efficacy biomarker for chronic lymphocytic leukemia (CLL) and on March 4, 2013, to discuss the endpoint for acute myelogenous leukemia (AML). ...