Tregzi cleared for matched-donor HSCT in hematologic malignancies
- Sponsor
- Orca Bio
- Drug
- Tregzi · allogeneic regulatory T cell-based immunotherapy with HSPC and T cells-vldq
- Indication
- Adult patients undergoing matched-donor allogeneic HSCT for hematologic malignancies (AML, ALL, high-risk MDS, mixed-phenotype acute leukemia)
FDA approved Orca Bio's Tregzi for adult patients undergoing matched-donor allogeneic hematopoietic stem cell transplantation with a myeloablative preparative regimen — the first precision-engineered allogeneic regulatory T cell therapy authorized in the U.S. Approval covers hematopoietic and immunologic reconstitution and improvement of chronic graft-versus-host-disease-free survival.
Read original at fda.gov ↗From the source
FDA Approves New Treatment That Uses Donor Immune Cells to Prevent Serious Complications in Blood Cancer Patients
For Immediate Release: June 30, 2026
Today, the U.S. Food and Drug Administration approved Tregzi (allogeneic regulatory T cell-based immunotherapy with hematopoietic stem and progenitor cell (HSPC) and T cells-vldq) for use in matched- donor hematopoietic stem cell transplantation (HSCT) with a myeloablative preparative regimen for adult patients with hematologic malignancies, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndromes (MDS), and mixed-phenotype acute leukemia. The indication is for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease (cGVHD)-free survival.
Tregzi is the first precision-engineered allogeneic regulatory T cell-based immunotherapy approved by the FDA. It is manufactured from a matched donor's collected cells, which are then sorted into the therapy's constituent cell populations.
Approval was supported by the Precision-T trial (n=187), a randomized, controlled study evaluating Tregzi versus conventional alloHSCT in adults with hematologic malignancies. The trial met its primary endpoint of chronic GVHD-free survival at one year post- transplant.
Reproduced from FDA Press Releases · view original · public domain or open-licensed government work