Orca Bio’s TREGZI™ Receives U.S. FDA Approval as First and Only Precision-Engineered Cell Therapy for Allogeneic Transplant in Adults with Hematological Malignancies
The approval of TREGZI, clinically known as Orca-T®, marks a significant milestone for patients as a novel, personalized cell therapy for use in a stem cell transplant to improve survival free of chronic graft versus host disease (GVHD) in adults with hematological malignancies
Approval is based on the pivotal Precision-T study which demonstrated patients receiving TREGZI were twice as likely to be alive without chronic GVHD at one year compared with conventional allogeneic transplant
TREGZI is Orca Bio’s first approved therapy, validating the company’s high-precision platform and the potential of its pipeline
Orca Bio, a commercial-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced the U.S. Food and Drug Administration (FDA) has approved TREGZI™ (allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq), clinically known as Orca-T®, 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.
