US FDA approves Orca Bio's blood cancer therapy

 The U.S. Food and Drug Administration today approved Tregzi, the first regulatory T (Treg) cell-based immunotherapy for improving chronic graft-versus-host disease (GVHD)-free survival in adult patients with blood cancers undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). It represents a novel approach to allogeneic hematopoietic stem cell transplantation in some adult patients with high-risk blood cancers. It addresses an important unmet need in transplantation, where curing the cancer is often only part of the challenge; avoiding chronic GVHD is equally important for long-term outcomes.

Tregzi uses stem cells and immune cells collected from blood of a closely matched donor to help the body fight cancer while reducing the risk of a serious complication called chronic GVHD — a condition that can occur when transplanted donor blood cells attack the patient's body. Patients receive this treatment after undergoing chemotherapy to prepare their bodies for a bone marrow or stem cell transplant.

"For patients with blood cancers who need stem cell transplantation, chronic graft-versus-host disease has long been one of the most feared and difficult-to-prevent complications," said Karim Mikhail, B.Pharm., M.S., Acting Director of the Center for Biologics Evaluation and Research (CBER). "Today's approval offers a genuine new approach that can help reconstitute the immune system while substantially reducing that risk and reflects the promise of what cellular therapy can deliver for patients."  

Tregzi is a donor-derived cellular immunotherapy composed of three cell components: purified hematopoietic stem and progenitor cells (HSPCs), Treg cells, and conventional T (Tcon) cells, each derived from the mobilized peripheral blood of an 8/8 HLA-matched related or unrelated donor. Treg cells are a type of immune cell that help regulate immune responses and maintain immune tolerance. Tregzi is designed to reduce the risk of chronic GVHD during reconstitution of the patient's blood-forming and immune systems.  

The FDA granted approval of Tregzi to Orca Biosystems, Inc.

https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-uses-donor-immune-cells-prevent-serious-complications-blood-cancer