Reflections on clinical development and evaluation of drugs for graft-versus-host disease treatment
Graft-versus-host disease(GvHD)is a major complication and cause of death in allogeneic hematopoietic stem cell transplantation recipients.According to clinical characteristics,it is mainly divided into acute GvHD and chronic GvHD,which may impair multiple organs such as skin,liver,and gastrointestinal tract.GvHD is a serious and highly heterogeneous disease.Corticosteroids are the first-line systemic treatment for GvHD,and steroid refractory GvHD patients have a poor prognosis.In recent years,the development of GvHD new drugs has become a hot topic.Ibrutinib,ruxolitinib,and belumosudil have been approved for the treatment of GvHD over the world.There are also several innovative drugs in different phases of clinical trials in China.This paper summarizes the clinical development experiences of recently listed drugs and the regulatory considerations of foreign countries.Some considerations are put forward from the perspective of drug evaluation based on clinical needs,disease and drug characteristics,differences at home and abroad,in order to provide reference for the clinical research and evaluation.
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