The FDA’s June approvals included Orca-T (Tregzi), an allogeneic regulatory T cell therapy designed for patients with hematological malignancies undergoing matched-donor hematopoietic stem cell transplantation. The approval introduces a cell therapy modality intended to rebuild immune tolerance while limiting graft-versus-host disease. Orca-T/Tregzi is positioned alongside a myeloablative preparative regimen to support hematopoietic and immunologic reconstitution. By using purified regulatory T cells from a donor graft, the therapy aims to preserve cancer-directed immune response while reducing chronic GVHD burden. The approval is notable for the platform’s attempt to standardize supply through an off-the-shelf, allogeneic approach—an area where manufacturing consistency and potency validation are pivotal. It also increases the addressable market for next-generation Treg therapies in transplant settings. Clinically, the key question for uptake will be long-term chronic GVHD-free survival outcomes and how the product performs across real-world transplant workflows compared with other GVHD mitigation strategies.