FDA Approves Orca Bio’s TREGZI for Allogeneic Hematopoietic Transplants
On June 30, 2026, Orca Bio announced that the U.S. Food and Drug Administration (“FDA”) approved TREGZI 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-free survival, in the treatment of adults with hematological malignancies.
TREGZI is manufactured individually for each patient using cells collected from a matched donor. The therapy combines hematopoietic stem and progenitor cells (HSPCs), regulatory T cells (Tregs), and conventional T cells (Tcons) to reconstitute the immune system.
The FDA granted approval based on data from Orca Bio’s Phase 3 Precision-T clinical trial, with 78% of patients receiving TREGZI seeing higher rates of GVHD-free survival, compared to 38% of patients who underwent conventional allogenic hematopoietic stem cell transplant (alloHSCT).
This is Orca Bio’s first regulatory approval.
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