FDA has approved Orca Bio’s personalized T-cell therapy Tregzi for blood cancer patients undergoing stem cell transplants, with the agency targeting reduction in graft-versus-host disease risk. The approval positions Tregzi as an alternative to matched-donor approaches for selected curative-intent patients, aiming to change the benefit-risk tradeoff in transplant settings. Orca said the therapy is designed to lower the risk of debilitating immune complications that can follow transplantation, which historically has limited long-term outcomes even when remission rates are achievable. The company framed the approval as a potential survival benefit with fewer chronic sequelae.