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.
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.
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.
CRISPR Therapeutics said CASGEVY launch momentum is building and multiple pipeline assets could generate data in the next 12 to 18 months. The company also highlighted zugo-cel progress in oncology and autoimmune disease.
A first-in-human trial shows individualized neoantigen mRNA vaccines generated multi-year T cell responses in early-stage TNBC patients, with 82.9% of targeted mutations eliciting measurable immune activation not detectable before vaccination.
