Lifileucel: First Approval

<div><strong>Declarations</strong></div> <div><strong>Funding</strong> The preparation of this review was not supported by any external funding.</div> <div><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.</div> <div><strong>Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability</strong> not applicable</div> <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> <div><strong>Abstract</strong> </div> <p>Lifileucel (AMTAGVI™), a one-time autologous T cell therapy derived and expanded from tumour-infiltrating lymphocytes (TIL) from a patient’s own tumour, is being developed by Iovance Biotherapeutics, Inc. for the treatment of cancer. Lifileucel was granted accelerated approval based on objective response rate (ORR) in February 2024 in the USA for use in adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if <em>BRAF</em> V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This article summarizes the milestones in the development of lifileucel leading to this first approval for the treatment of patients with unresectable or metastatic melanoma who have progressed on or after prior anti-PD-1/L1 therapy and targeted therapy.</p> <p>© Springer Nature Switzerland AG 2024</p>