FDA Approves TREGZI™ – a Game-Changing Cell Therapy for Transplant Patients

This summer Orca Bio announced that the U.S. Food and Drug Administration (FDA) has approved TREGZI™ (allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq; Orca-T®). TREGZI 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 is used to improve chronic graft-versus-host disease (GVHD)-free survival (cGFS) in the treatment of adults with haematological malignancies.

TREGZI works by using hematopoietic stem and progenitor cells to reconstitute the immune system, highly purified regulatory T cells to suppress GVHD, and conventional T cells to accelerate immune reconstitution and produce graft-versus-leukemia (GVL) activity. It is a personalized treatment manufactured for each individual patient using living cells from a matched donor.

Approval was based on the randomized, multi-centre Precision-T Phase 3 study, which included 187 patients with AML, ALL, MDS and MPAL. Data from the study demonstrated that patients receiving TREGZI were twice as likely to be alive without chronic GVHD at one year compared with conventional allogeneic transplant.

“Historically, surviving a blood cancer has often meant navigating serious, long-term effects that can shape patients’ lives well beyond treatment,” said Gwen Nichols, M.D., executive vice president and chief medical officer at Blood Cancer United. “As a researcher, physician and a patient advocate, it’s exciting that patients will have a new option that may change what life after transplant can look like, including the potential to support recovery and quality of life.”

To read more about this news, please visit: Orca Bio