← Back to The Docket — Tregzi (Orca-T)
for Adult patients undergoing matched-donor allogeneic HSCT with a myeloablative preparative regimen — hematopoietic and immunologic reconstitution + improvement of chronic GVHD-free survival
BLA · Priority Review · RMAT · Orphan
FDA approved Orca Bio's Tregzi (Orca-T) on 2026-06-30, six days ahead of the extended PDUFA target — the first precision-engineered allogeneic regulatory T cell-based immunotherapy authorized in the U.S. Approval covers matched-donor allogeneic HSCT with a myeloablative regimen in adults with AML, ALL, high-risk MDS, and mixed-phenotype acute leukemia. Precision-T pivotal (n=187) reported one-year cGVHD-free survival of 78% vs 38% with conventional alloHSCT.
About
Tregzi is a donor-derived cell therapy that delivers a precisely engineered mix of immune cells, including regulatory T cells, to a patient receiving a stem cell transplant. This approach aims to rebuild the patient's blood and immune systems while specifically calming the immune reactions that can attack healthy tissues. By potentially reducing harmful immune responses, it may improve a patient's recovery without the severe, long-term complications often associated with transplants.
Pivotal trial
To assess the safety of administering allogenic, donor-derived CD19/CD22-CAR T cells that meet established release specifications in adults with B-cell ALL following a myeloablative conditioning regimen and Orca-T to determine if this will augment graft versus leukemia without increasing acute GVHD or graft failure.
Source: ClinicalTrials.gov
PDUFA history
- → APR 6 2026 shifted to JUL 6 2026 (Major amendment — updated CMC information submitted in response to FDA requests; not a safety or efficacy concern; announced APR 1 2026)
