FDA approves Tregzi, first regulatory T-cell therapy to prevent chronic graft-versus-host disease in blood cancer transplant patients
Blood cancer patients needing a donor stem cell transplant just gained a defense against a deadly complication. The FDA approved Tregzi on July 1, the first regulatory T-cell therapy. In its trial, 78% stayed alive and GVHD-free at one year, vs 38% on standard transplants. Per th
For patients with blood cancers, an allogeneic stem cell transplant can be lifesaving, but it carries a serious risk of its own. When transplanted donor cells recognize the recipient's body as foreign, they can attack healthy tissue in a chronic, sometimes disabling condition called graft-versus-host disease. On July 1 the FDA approved Tregzi, the first therapy of its kind designed to keep that reaction in check. Tregzi is built from three cell populations drawn from a single closely matched donor: purified blood-forming stem cells, regulatory T cells that calm the immune response, and conventional T cells that still fight the cancer. The regulatory T cells act as a brake, so the graft protects the patient without turning against them. The approval rests on the PRECISION-T trial. At one year, 78% of patients treated with Tregzi were alive and free of chronic graft-versus-host disease, compared with 38% who received a standard transplant. The therapy requires an 8/8 human leukocyte antigen match, so donor availability will shape who can receive it. Per the FDA.