Orca-T: First Approval.

Abstract

Allogeneic regulatory T cell immunotherapy with haematopoietic stem and progenitor cells (HSPC) and T cells-vldq, hereafter referred to as Orca-T (TREGZI™), has been developed by Orca Bio under license from Stanford University for the prevention of chronic graft-versus-host disease (cGVHD). On 30 June 2026, Orca-T received its first approval in the USA for use in matched donor haematopoietic stem cell transplantation (HSCT) with myeloablative preparative regimen, for haematopoietic and immunologic reconstitution and to improve cGVHD-free survival, in the treatment of adults with haematological malignancies. This article summarizes the milestones in the development of Orca-T leading to this first approval for the prevention of cGVHD.