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Review
. 2024 Jun;10(6):475-477.
doi: 10.1016/j.trecan.2024.04.003. Epub 2024 May 9.

Lifileucel: the first cellular therapy approved for solid tumours

Max Julve  1 , Mark P Lythgoe  2 , James Larkin  3 , Andrew J S Furness  3
Affiliations
Review

Lifileucel: the first cellular therapy approved for solid tumours

Max Julve et al. Trends Cancer. 2024 Jun.

Abstract

The US Food and Drug Administration (FDA) approval of lifileucel, for advanced melanoma, represents the first cellular therapy to reach the clinic for solid cancers. Here, we summarise this landmark approval, consider the associated regulatory pathway, and evaluate the challenges that remain to ensure effective implementation of this advanced 'living' therapy.

Keywords: FDA approval; cell therapy; immunotherapy; lifileucel; melanoma; tumour infiltrating lymphocyte therapy.

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Conflict of interest statement

Declaration of interests M.P.L. and M.J. declare no conflicts of interest. J.L. declares the following: honorariums (Eisai, Novartis, Incyte, Merck, touchIME, touchEXPERTS, Pfizer, Royal College of Physicians, Cambridge Healthcare Research, Royal College of General Practitioners, VJOncology, Agence Unik, BMS, Immatics, Insighter, and GCO); consultancies (iOnctura, Apple Tree, Merck, BMS, Eisai, Debipharm, Incyte, Pfizer, Novartis, MSD. Speaker fee: Pierre Fabre, BMS, Ipsen, Roche, EUSA Pharma, Novartis, Aptitude, AstraZeneca, GSK, Eisai, Calithera, Ultimovacs, Seagen, Merck, eCancer, Inselgruppe, Pfizer, Goldman Sachs, MSD, Regional British Society of Gastroenterology, and Agence Unik); institutional research support (BMS, MSD, Novartis, Pfizer, Achilles Therapeutics, Roche, Nektar Therapeutics, Covance, Immunocore, Pharmacyclics, and Aveo); and grants (Achilles, BMS, MSD, Nektar, Novartis, Pfizer, Roche, Immunocore, Aveo, and Pharmacyclics). A.J.S.F. declares the following: speakers bureau and educational events (BMS, Eisai, Ipsen, Merck, and Pfizer); support for attending meetings and/or travel (Achilles Therapeutics, Adaptimmune, ESMO, Iovance Biotherapeutics. Advisory Boards: Achilles Therapeutics, GSK, Immunocore, and Neogene); and patents planned, issued, or pending: WO2019008375A1 (co-inventor of methods of identifying responders to cancer treatment).

References

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