The FDA cleared Orca Bio’s Tregzi (formerly Orca-T), marking the first approval for a cell therapy built on regulatory T cells (Tregs) rather than the more common conventional T-cell approach. The indication targets outcomes in matched-donor allogeneic HSCT for adults with hematologic malignancies, aiming to reduce chronic graft-versus-host disease (GVHD) risk while supporting immune reconstitution. Orca’s approval draws on results from the Phase 3 Precision-T program, with the company positioning Tregzi as an alternative that changes the transplant “trade-off” between curative potential and long-term immune complications. The decision also sets a reference point for future off-the-shelf Treg strategies in transplantation, where timing, manufacturing consistency, and GVHD reduction have remained central unmet needs. Regulatory and clinical stakeholders will now watch real-world uptake and whether Tregzi’s safety and efficacy translate broadly across transplant centers using standardized preparative regimens.