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FDA’s June approvals included a Treg cell therapy

Three NMEs bring total for 1H26 to 23

July 14, 2026 11:56 PM UTC

FDA’s June approvals included Tregzi, the first approved allogeneic Treg-based cell therapy, introducing a new cell therapy modality for patients with hematological malignancies undergoing matched-donor hematopoietic stem cell transplantation.

Also known as Orca-T, Tregzi is a precisely composed donor-cell graft designed to rebuild the patient’s blood and immune system, preserve an immune response against the cancer, and use purified regulatory T cells to limit the reactions that cause graft-versus-host disease. It is used with a myeloablative preparative regimen to support hematopoietic and immunologic reconstitution and improve chronic graft-versus-host disease-free survival...