In preparation for a potential “paradigm shift” in the management of graft-versus-host disease (GVHD), the US Food and Drug Administration (FDA) is seeking comment on draft guidance for developing drugs, biological products, therapeutic devices, and cell processing devices for the prevention or treatment of acute graft-versus-host disease (aGVHD) or chronic graft-vs-host disease (cGVHD) after allogeneic hematopoietic stem cell transplantation (HSCT).
Traditionally, GVHD in this setting has been addressed with drugs or with physical methods aimed at depleting the reactive immune cells immediately after transplant. But GVHD is potentially a lifelong post-transplant problem; prolonged immunosuppression carries serious health risks, including infections and malignancy that might otherwise be controlled by normal immune function…
