FDA Approves First Regulatory T-Cell Therapy for Chronic GVHD Prevention
- nuaxia
- 2 days ago
- 2 min read
The FDA has approved Tregzi, the first regulatory T (Treg) cell-based immunotherapy to improve chronic graft-versus-host disease (GVHD)-free survival in adults with blood cancers undergoing allogeneic stem cell transplantation, marking a major advance in cellular therapy and transplant medicine.
The approval is supported by the Phase III PRECISION-T trial, in which Tregzi significantly reduced the incidence of chronic GVHD while nearly doubling one-year GVHD-free survival compared with standard stem cell transplantation.
Alert Type | Regulatory Approval (FDA) |
Drug Name | Imfinzi (durvalumab) + Bacillus Calmette-Guérin (BCG) |
Indication | BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC) in adults |
Therapy Area(s) | Oncology, Urology, Bladder Cancer, Immuno-oncology |
Geography | United States (FDA approval) |
What Changed | The FDA approved AstraZeneca’s Imfinzi (durvalumab) in combination with BCG induction and maintenance therapy for adults with BCG-naïve, high-risk NMIBC. Based on the Phase III POTOMAC trial, the combination reduced the risk of high-risk disease recurrence, progression, or death by 32% compared with BCG alone, becoming the first approved immunotherapy combination in this setting. |
Clinical Relevance | The approval introduces a new treatment paradigm for high-risk NMIBC by adding immunotherapy to the long-established BCG backbone. The regimen demonstrated durable disease-free survival benefits over more than five years of follow-up while maintaining a manageable safety profile, preserving BCG treatment completion rates, and not negatively affecting patient-reported quality of life. |
Source Link | |
Date | 1-Jun-2026 |
Status | Draft |
Notes | POTOMAC Phase III data showed a disease-free survival hazard ratio of 0.68 with a median follow-up of 60.7 months. No new safety signals were identified versus the known profiles of Imfinzi and BCG. Regulatory reviews are ongoing in the EU, Japan, and other markets. The approval further expands Imfinzi’s role across the bladder cancer treatment pathway alongside ongoing Phase III programmes including VOLGA, NIAGARA, and NILE. |
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