FDA Approves Tregzi — First Regulatory T-Cell Therapy for Blood Cancer Transplants

The FDA approved allogeneic regulatory T cell-based immunotherapy with hematopoietic stem and progenitor cells and T cells-vldq (Tregzi, Orca Bio; formerly Orca-T) for use in matched donor hematopoietic stem cell transplantation with a myeloablative preparative regimen in adults with hematologic malignancies. Tregzi is engineered from highly purified regulatory T cells and is intended to improve hematopoietic and immunologic reconstitution while reducing chronic graft-versus-host disease (cGVHD)-free survival risk after transplant — it is the first treatment built from precision-purified Tregs to reach the US market, targeting a major cause of transplant-related morbidity and mortality in blood cancer patients.