Minimal Residual Disease as a Surrogate Endpoint in Hematologic Cancer TrialsRegister
Vishal Bhatnagar, US Food and Drug Administration
John Byrd, The Ohio State University
Jennifer Dickey, US Food and Drug Administration
Christopher Hourigan, National Heart, Lung, and Blood Institute (NHLBI)
Ola Landgren, Memorial-Sloan Kettering Cancer Center
Jerald Radich, Fred Hutchinson Cancer Center
Daniel Sargent, Mayo Clinic
In order to support the goal of expediting the development and review of innovative new medicines intended to address unmet medical needs for serious or life-threatening diseases (FDASIA 901(a)(c)), the Duke-Margolis Center, under a cooperative agreement with the U.S. Food and Drug Administration, will hold a public meeting to advance the discussion around the validation and use of minimal residual disease (MRD) as a surrogate endpoint in clinical trials for hematologic malignancies.
The objectives for the day’s discussion are to: 1) Discuss the regulatory background for use of MRD as a surrogate endpoint for regulatory decisions; 2) Explore the statistical basis for demonstrating and validating surrogacy; and 3) Present the evidence available to support the use of MRD as a surrogate endpoint in clinical trials in new treatments of acute myeloid leukemia, acute lymphocytic leukemia, chronic lymphocytic leukemia, and multiple myeloma.