FDA approves Orca Bio Tregzi first regulatory T-cell therapy for chronic GVHD-free survival in blood cancer transplant
Blood cancer patients facing a stem-cell transplant have a new option against a feared complication. The FDA approved Orca Bio's Tregzi, the first regulatory T-cell therapy to improve chronic GVHD-free survival. In PRECISION-T, 78% were free at one year vs 38% with a standard tra
Blood cancer patients preparing for a stem-cell transplant now have a tool against one of the procedure's most feared long-term complications. On June 30, 2026, the FDA approved Orca Bio's Tregzi, the first regulatory T-cell immunotherapy indicated to improve chronic graft-versus-host-disease-free survival in adults with blood cancers undergoing a matched-donor allogeneic transplant. Chronic GVHD occurs when transplanted donor immune cells attack the recipient's own tissues, and it can leave survivors with lasting damage to skin, eyes, gut and lungs. Tregzi is a precision-engineered graft that combines three components: purified stem cells to rebuild the immune system, regulatory T cells to hold that immune response in check, and conventional T cells to preserve the graft-versus-leukemia effect that keeps cancer from returning. In the PRECISION-T trial, 78% of patients were free of chronic GVHD at one year, compared with 38.4% on a standard transplant, while the chronic GVHD rate fell to 13% from 44%. The significance is less a single number than a shift in what a transplant can promise: not only surviving the cancer, but surviving it without a second disease taking its place. Source: STAT News.