Orca Bio’s Tregzi wins FDA approval

Privately-held US cell therapy company Orca Bio announced the US Food and Drug Administration (FDA) has approved Tregzi (allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq), clinically known as Orca-T.

This is a precision-engineered cell therapy for use in matched-donor hematopoietic stem cell transplantation with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease (GVHD)-free survival (cGFS), in the treatment of adults with hematological malignancies.