Tumour-infiltrating lymphocyte therapy in melanoma: ready for prime time?

Abstract Tumour infiltrating lymphocyte (TIL) therapy offers the potential for durable clinical benefit in select patients with advanced melanoma, especially after progression on treatment with immune checkpoint inhibitors and/or targeted therapies. The 2024 FDA approval of Lifileucel (Amtagvi), a commercially manufactured autologous TIL product, marks a key milestone in integrating advanced therapy medicinal products (ATMPs) into routine care for solid tumours. Health Canada has since approved Lifileucel, with regulatory and funding decisions across the UK and Europe still pending. In this Perspective, we review the evidence base and outline key considerations for national adoption of TIL therapy. Despite promising results from clinical trials, TIL therapy requires complex coordination, including patient selection, tumour procurement, manufacturing logistics, lymphodepletion, and IL-2 administration; all contingent on specialised infrastructure and well-considered integrated care pathways. While commercial centralisation may ease logistical barriers, the high cost of TIL therapy necessitates careful health economic evaluation. A nationally coordinated effort is required to harmonise clinical prioritisation strategies, maintain oversight by multidisciplinary specialist tumour boards, and consider investment in future-proof decentralised manufacturing capacity. Collaborations and peer support such as through the Advanced Therapy Treatment Centre (ATTC) Network will facilitate phased, experience-led rollout with equity-focused service design.