The U.S. Food and Drug Administration said on Tuesday it has approved Orca Bio's therapy for the treatment of certain blood cancers, which also aims to lower the risk of stem cell transplant complications.
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 privately held biotech's CEO, Nate Fernhoff, told Reuters the therapy will have an acquisition cost of $428,000 for wholesalers, adding that the company expects it to be available for orders by the end of July.
Fernhoff said Orca-T's key benefit is improving survival free from chronic graft-versus-host disease, or GvHD, calling it a "more fully restorative treatment" for blood cancer patients.
The approval was based on a late-stage trial in which 78% of patients who received Orca-T were alive and free from moderate-to-severe chronic GvHD at one year, compared with 38% of those who received a conventional transplant.
GvHD is a transplant complication in which donor immune cells attack the patient's healthy tissues. It can damage organs, require long-term immune-suppressing drugs, increase infection risk and can be fatal.
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.
