← 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 cell therapy made from a donor's blood that contains a precisely balanced mix of immune cells, including regulatory T cells designed to help control immune reactions. It is given to patients as part of a stem cell transplant to rebuild their blood and immune systems. This engineered cell population may improve transplant outcomes by promoting healing while potentially reducing the risk of chronic complications from the donor immune system attacking the body.
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)
