The FDA approved Orca Bio’s personalized T-cell therapy, branded Tregzi, for matched-donor allogeneic hematopoietic stem cell transplantation (HSCT) in adults with hematologic malignancies. Orca positioned the treatment as a way to reduce chronic graft-versus-host disease and improve graft-free survival outcomes. Orca said the approval is based on data submitted for its Phase III Precision-T program, targeting patients receiving myeloablative preparative regimens. The company will use the label to expand a regulatory T-cell-based approach that differs from conventional stem-cell transplant conditioning and matching alone. The approval marks a milestone category shift for cell therapies, with Tregzi described as a first-of-its-kind cell therapy centered on regulatory T cells for transplant-related complications.