The FDA has approved Orca Bio’s personalized T-cell therapy for matched-donor allogeneic HSCT patients with hematologic malignancies, bringing the company’s precision-engineered cell therapy approach to market under the brand name Tregzi (formerly Orca-T). The therapy is designed to reduce transplant-related complications, including chronic graft-versus-host disease (GVHD), while supporting hematopoietic and immunologic reconstitution. Orca Bio said Tregzi is indicated for adults with hematologic malignancies (including AML, ALL, MDS, and mixed-phenotype acute leukemia) undergoing myeloablative preparative regimens. The approval follows the company’s Phase III Precision-T trial data and submission of its BLA in 2025. The approval lands amid ongoing competition among post-transplant cell therapy strategies targeting GVHD risk and long-term outcomes, with Tregzi positioned as an alternative approach to traditional matched-donor transplantation tradeoffs.