TREGZI
STN: BLA 125868
Proper Name: allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq
Tradename: TREGZI
Manufacturer: Orca Biosystems Inc
Indications:
- For use in matched donor hematopoietic stem cell transplantation with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease (cGVHD)-free survival, in the treatment of adults with hematological malignancies
Product Information
- Package Insert - TREGZI
- Demographic Subgroup Information – TREGZI
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.