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FDA Pipeline: Designations for Acute Graft-vs-Host Disease, Peripheral T-Cell Lymphoma


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Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to a therapy for steroid-refractory acute graft-vs-host disease and granted Orphan Drug designation to a therapy for peripheral T-cell lymphoma.

Fast Track Designation for T-Guard in Steroid-Refractory Acute Graft-vs-Host Disease

The FDA granted Fast Track designation to T-Guard for steroid-refractory acute graft-vs-host disease in patients following allogeneic stem cell transplantation. T-Guard is designed to reset the body's immune system in life-threatening T-cell‒mediated conditions, including transplant-related rejection, acute solid organ rejection, and severe autoimmune disease.

T-Guard consists of a combination of toxin-conjugated monoclonal antibodies that target the CD3 and CD7 molecules on T cells and natural killer (NK) cells. Preclinical and early clinical testing have shown that T-Guard can specifically identify and eliminate mature T cells and NK cells with minimal treatment-related side effects. A phase I/II study of T-Guard for the second-line treatment of steroid-refractory acute graft-vs-host disease in patients following hematopoietic stem cell transplantation were published in Biology of Blood and Marrow Transplantation.

A U.S. phase III registration trial involving patients with steroid-refractory acute graft-vs-host disease following allogeneic stem cell transplantation will begin soon. T-Guard has also been granted Orphan Drug designation status in both the European Union and the United States.

Orphan Drug Designation for Duvelisib in Peripheral T-Cell Lymphoma

The FDA granted Orphan Drug designation to duvelisib for the treatment of peripheral T-cell lymphoma. Duvelisib is a dual inhibitor of PI3Kδ and PI3Kγ approved in the United States for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma after at least two prior therapies and in follicular lymphoma after at least two prior systemic therapies.

Peripheral T-cell lymphoma is a rare, aggressive non-Hodgkin lymphoma that accounts for between 10% and 15% of all non-Hodgkin lymphomas and generally affects people aged 60 years old and older. The ongoing phase II PRIMO study will provide guidance on a duvelisib monotherapy dosing regimen in patients with relapsed or refractory peripheral T-cell lymphoma and further characterize its efficacy and tolerability in this population. 

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
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