US FDA approves Orca Bio's blood cancer therapy

The U.S. Food and Drug Administration has approved Orca Bio's cell therapy for the treatment of certain blood cancers, the regulator said on Tuesday.

The therapy, called Orca-T, brand name Tregzi, aims to treat patients with blood cancers including acute myeloid leukemia, acute lymphoblastic leukemia and myelodysplastic syndromes.

Orca-T is designed to rebuild a patient's damaged blood and immune system using healthy blood-forming and immune cells from a matched donor, while reducing serious complications associated with conventional donor stem cell transplants.

The therapy is made by separating donor blood into specific cell types, including regulatory T cells to control graft-versus-host disease, stem cells to rebuild the blood and immune system, and conventional T cells to help fight infections and cancer relapse.

(Reporting by Kunal Das, Kamal Choudhury and Puyaan Singh in Bengaluru; Editing by Sahal Muhammed)

Copyright Reuters or USA Today Network via Reuters Connect

This story was originally published June 30, 2026 at 3:03 PM.