The FDA has approved Orca Bio’s Tregzi, the first cell therapy built on regulatory T cells, to reduce the risk of chronic graft-versus-host disease in patients undergoing matched-donor allogeneic HSCT for hematologic malignancies. The decision follows data from Orca Bio’s Phase III Precision-T trial and expands access to a new alternative cell-therapy approach in a curative transplant setting. Orca’s Tregzi is positioned for adults receiving HSCT after myeloablative conditioning and is intended to improve chronic GVHD-free survival while supporting hematopoietic and immunologic reconstitution. The approval marks a milestone for Treg-based cellular therapies, which aim to control alloreactivity after transplant without compromising engraftment. The approvals also highlight regulatory momentum for next-generation living medicines beyond CAR-T and conventional immune cell constructs. Orca Bio has moved the therapy toward commercialization following manufacturing capacity expansion in preparation for launch. For transplant programs, the label adds a mechanism-driven option that could reshape benefit-risk tradeoffs in patient selection and center adoption, especially as HSCT practice increasingly emphasizes longer-term complication avoidance.