FDA Greenlights New Cell Therapy for Blood Cancer Patients

The U.S. Food and Drug Administration announced Tuesday that it has given the green light to a new cell therapy from Orca Bio aimed at fighting certain forms of blood cancer.

Known as Orca-T and sold under the brand name Tregzi, the treatment targets patients diagnosed with blood cancers such as acute myeloid leukemia, acute lymphoblastic leukemia, and myelodysplastic syndromes.

The therapy works by rebuilding a patient’s compromised blood and immune system using healthy blood-forming and immune cells sourced from a compatible donor. It is designed to reduce the serious complications that can arise with traditional donor stem cell transplants.

To create the treatment, donor blood is carefully separated into distinct cell types. These include regulatory T cells, which help keep graft-versus-host disease in check, stem cells to restore the blood and immune system, and conventional T cells that assist in fighting off infections and preventing cancer from returning.