Posted by Michael Wonder on 16 Oct 2018
FDA guides on minimal residual disease endpoint in haematologic cancer trials
16 October 2018 - FDA Commissioner Scott Gottlieb highlighted minimal residual disease's potential as a surrogate endpoint in clinical trials when he unveiled FDA's draft guidance on using minimal residual disease in haematologic malignancy drug development in a statement Monday.
As early as 2012, FDA co-sponsored public workshops "to gain a better understanding of the state of the science of MRD," the agency wrote in the guidance.
Gottlieb pointed to emerging technologies, such as the newly approved clonoSEQ assay from Adaptive Biotechnologies, as contributing to a paradigm shift where MRD assessments could be useful in clinical trials or help expedite development. FDA approved clonoSEQ last month to detect MRD in acute lymphoblastic leukaemia or multiple myeloma patients. The in vitro diagnostic is capable of detecting MRD at levels below 1 in 1 million cells.
