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Aug 08, 2026
The FDA approved Tregzi (Orca-T), a first-of-its-kind regulatory T cell-based immunotherapy, for adults with blood cancers undergoing matched donor stem cell transplants. Approval was based on the PRECISION-T trial, in which 78% of treated patients achieved chronic GVHD-free survival at one year versus 38.4% with standard transplant.
Jul 20, 2026
The FDA approved Orca-T (Tregzi) for matched donor hematopoietic stem cell transplantation in adults with hematologic malignancies. Phase 3 Precision-T data showed reduced graft-versus-host disease across leukemia and MDS populations, with experts calling it a 'big advance' requiring further comparison with post-transplant cyclophosphamide.
Jul 21, 2026
The FDA has approved Tregzi, a donor-derived T-cell immunotherapy, to reduce the risk of chronic graft-versus-host disease following stem cell transplant in adults with high-risk blood cancers. In a pivotal trial, 78% of recipients were alive and free of severe chronic GVHD at one year versus 38.4% with standard transplant.
Apr 06, 2026
The 2026 Tandem Meetings featured new data on CAR-T, allogeneic transplantation, and supportive care. Highlights included early efficacy signals for EB-103, KITE-753, Orca-T, and NXC-201, plus comparative cardiovascular safety data for lisocabtagene maraleucel.
Mar 18, 2026
The FDA is set to make decisions on four drug applications in April 2026, including Orca-T for hematological malignancies, orforglipron for obesity, sparsentan for kidney disease, and a doravirine/islatravir combination for HIV-1.
Feb 19, 2026
Orca-T, an investigational T-cell therapy under FDA priority review, is being studied to reduce graft-versus-host disease in patients undergoing allogeneic stem cell transplant for acute leukemias and high-risk blood disorders, with a decision expected in April 2026.
