Lifileucel: the first cellular therapy approved for solid tumours

Max Julve; Mark P Lythgoe; James Larkin; Andrew J S Furness

doi:10.1016/j.trecan.2024.04.003

Lifileucel: the first cellular therapy approved for solid tumours

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

Authors

Max Julve¹, Mark P Lythgoe², James Larkin³, Andrew J S Furness³

Affiliations

¹ Department of Medical Oncology, The Royal Marsden NHS Foundation Trust, London, UK. Electronic address: Maximilian.julve@nhs.net.
² Department of Surgery and Cancer, Imperial College London, Du Cane Road, W12 0HS, London, UK.
³ Department of Medical Oncology, The Royal Marsden NHS Foundation Trust, London, UK.

PMID: 38724322
DOI: 10.1016/j.trecan.2024.04.003

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.

Publication types

Review

MeSH terms

Drug Approval*
Humans
Immunotherapy, Adoptive / methods
Lymphocytes, Tumor-Infiltrating
Melanoma / drug therapy
Melanoma / immunology
Melanoma / pathology
Melanoma / therapy
Neoplasms / drug therapy
Neoplasms / immunology
Neoplasms / therapy
United States
United States Food and Drug Administration*

Substances

lifileucel