Tabelecleucel: First Approval

<p><strong>Declarations</strong></p> <p><strong>Funding</strong> The preparation of this review was not supported by any external funding.</p> <p><strong>Authorship and Conflict of interest</strong> During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Susan J. Keam is a contracted employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.</p> <p><strong>Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability</strong> not applicable</p> <p>Additional information about this Adis Drug Review can be found<a href="https://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews" target="_blank"> here.</a></p> <p><strong>Abstract</strong> </p> <p>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. </p> <p>© Springer Nature Switzerland AG 2023</p>