The US Food and Drug Administration approved Orca Bio’s allogeneic regulatory T cell-based immunotherapy with hematopoietic stem and progenitor cell and T cells-vldq (Tregzi) for adults with hematologic malignancies.
The therapeutic indication covers patients undergoing matched donor hematopoietic stem cell transplantation alongside a myeloablative preparative regimen to facilitate immunologic reconstitution and improve chronic graft-versus-host disease-free survival, according to Orca Bio.
Clinical data supporting the approval were from the randomized phase 3 Precision-T trial comparing the personalized regimen against conventional unmanipulated allograft strategies. Treatment yielded a 12-month chronic graft-versus-host disease-free survival rate of 78% compared to 38.4% in the standard transplant control group.
This FDA approval follows an expedited priority review program and marks the first authorized allogeneic regulatory T cell-based immunotherapy in transplant medicine, according to a press release from Orca Bio.
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