US approval of Orca’s Tregzi landmark advance for stem cell transplants
FDA’s authorisation based on data showing the precision-engineered cell therapy improved survival free of GVHD in adults with haematological malignancies.
The US Food and Drug Administration (FDA) has approved the first precision-engineered cell therapy for allogeneic transplant in adults with haematological malignancies.
This authorisation of Orca Bio’s Tregzi (allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq), also known as Orca-T, represents the agency’s first approval of a treatment that uses highly purified Tregs.
The personalised cell therapy is designed for…
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