FDA Approves New Treatment That Uses Donor Immune Cells to Prevent Serious Complications in Blood Cancer Patients

The U.S. Food and Drug Administration today approved Tregzi, the first regulatory T (Treg) cell-based immunotherapy for improving chronic graft-versus-host disease (GVHD)-free survival in adult patients with blood cancers undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). It represents a novel approach to allogeneic hematopoietic stem cell transplantation in some adult patients with high-risk blood cancers. It addresses an important unmet need in transplantation, where curing the cancer is often only part of the challenge; avoiding chronic GVHD is equally important for long-term outcomes.Tregzi uses stem cells and immune cells collected from blood of a closely matched...