Yan Leyfman, Medical Oncologist, Co-Founder and Executive Director of MedNews Week, shared a post on LinkedIn:
“A major milestone in the field of allogeneic stem cell transplantation.
The FDA has approved TREGZI (Orca-T®), the first FDA-approved therapy to incorporate highly purified regulatory T cells (Tregs) as part of a matched-donor allogeneic stem cell transplant.
For decades, one of the biggest challenges in transplant has been balancing two competing goals:
- Preserve the graft-versus-leukemia effect.
- Minimize graft-versus-host disease (GVHD).
TREGZI was designed with that balance in mind.
The product combines:
- Hematopoietic stem and progenitor cells for engraftment
- Purified regulatory T cells to suppress GVHD
- Conventional T cells to support immune recovery and maintain anti-leukemia activity
In the phase 3 Precision-T trial, the results were impressive.
At one year:
- Chronic GVHD-free survival: 78% vs 38% with conventional allogeneic transplant
- Chronic GVHD: 13% vs 44%
- Overall survival: 94% vs 83%
- Non-relapse mortality: 3% vs 13%
Perhaps what excites me most is what this represents for the future of cellular therapy.
Rather than simply engineering cells to attack cancer, we’re now engineering the immune system to promote immune tolerance while preserving anti-tumor immunity. It’s a fundamentally different approach that could reshape how we think about allogeneic transplantation.
For patients with AML, ALL, MDS, and other hematologic malignancies undergoing matched-donor transplant, this approval has the potential to significantly improve not just survival, but life after transplant.
A very exciting day for the transplant community.”
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