FDA approves Tregzi, first T‑reg cell therapy to lower chronic GVHD risk in blood‑cancer transplants

The FDA announced approval of Tregzi, a regulatory T‑cell based immunotherapy designed to improve chronic graft‑versus‑host disease‑free survival for adults with blood cancers undergoing allogeneic hematopoietic stem cell transplantation.

The product uses donor‑derived stem and immune cells that are infused after the patient receives conditioning chemotherapy, aiming to rebuild the immune system while reducing the likelihood that donor cells will attack the recipient’s tissues.

Chronic GVHD has been a major source of morbidity after transplant, and the new therapy addresses a long‑standing gap by offering a strategy to prevent this complication without compromising the anti‑cancer effect of the transplant.

Regulators highlighted the therapy as a novel approach for high‑risk transplant patients, and experts said the approval could change standard practice for managing post‑transplant immune complications.