Tabelecleucel: First Approval.

Tabelecleucel (EbvalloTM) is an allogeneic Epstein-Barr virus (EBV)-specific T-cell immunotherapy that targets and eliminates EBV positive (EBV+) cells in a human leukocyte antigen (HLA) restricted manner. Tabelecleucel has been developed by Atara Biotherapeutics under a license from Memorial Sloan-Kettering Cancer Center (MSKCC) for the treatment of lymphoproliferative disorders (LPDs), including rituximab relapsed/refractory EBV+ post-transplant lymphoproliferative disease (PTLD). Tabelecleucel was granted marketing authorization under 'exceptional circumstances' on 16 December 2022 as monotherapy for the treatment of adult and paediatric patients 2 years of age and older with relapsed or refractory EBV+ PTLD who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate. This article summarizes the milestones in the development of tabelecleucel leading to this first approval for EBV+ PTLD.