FDA approves Orca Bio's engineered cell therapy for stem cell transplants
The FDA approved Tregzi , Orca Bio’s precision-engineered allogeneic cell therapy known in trials as Orca-T, for adults receiving matched-donor stem cell transplants to treat blood cancers including acute myeloid leukemia, acute lymphoblastic leukemia and myelodysplastic syndromes. The approval was granted June 30.
The therapy re-sorts a donor’s graft to add regulatory T cells alongside the transplanted stem cells and effector T cells, aiming to preserve the transplant’s cancer-fighting effect while suppressing graft-versus-host disease, the often disabling complication in which donor immune cells attack the recipient’s tissues. In the pivotal study, 78% of Tregzi recipients were alive and free of moderate-to-severe chronic GVHD at one year, compared with 38% of patients who got a conventional transplant.
Orca Bio set a wholesale acquisition cost of $428,000 and expects the product to be orderable by the end of July. The high price is characteristic of individualized cell therapies; the clinical case rests on cutting a complication that drives long-term illness, repeat hospitalization and cost after transplant.