Tabelecleucel

Tabelecleucel is an innovative therapy that uses Epstein-Barr virus (EBV)-specific allogeneic cytotoxic T cells (CTLs). It is produced by mixing T-cells with B-cells that have been infected with the Epstein-Barr virus (EBV). Both T-cells and B-cells are obtained from the same donor, and T-cells are grown to increase their numbers. When given to a patient with EBV-associated post-transplant lymphoproliferative disorder (PTLD) following solid organ transplantation (SOT) or hematopoietic cell transplant, T-cells attack the patient's own infected B-cells, thereby helping to control this condition.

In October 2022, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended tabelecleucel be granted marketing authorization for the treatment of adult and pediatric patients who experience EBV-associated post-transplant lymphoproliferative disorder (PTLD) following solid organ transplantation (SOT) or bone marrow transplantation (hematopoietic cell transplant - HCT). The FDA has granted tabelecleucel Breakthrough Therapy Designation for EBV-associated PTLD following allogeneic HCT.