Abstract
Cell therapy has revolutionised the landscape of cancer treatment, with therapies such as Chimeric Antigen Receptor T cells (CAR-T cells), showing remarkable efficacy in haematological malignancies, and approaches such as Tumour Infiltrating Lymphocytes (TILs) and T-cell receptor-engineered T cells (TCR-T) showing increasing promise in solid tumours. The recent US FDA approvals of lifileucel (a TIL therapy for advanced melanoma) and afamitresgene autoleucel (a TCR therapy targeting MAGE-A4 in synovial sarcoma) mark the first regulatory recognition of cell therapies for solid tumours and signal a new era for oncology. Europe has played a central role in these advances, leading pivotal phase 3 trials and pioneering hospital-exemption-based manufacturing programmes. However, the continent still faces major challenges, including fragmented regulatory frameworks, high manufacturing costs, and inequitable patient access across member states. Emerging innovations such as gene-edited, allogeneic, and iPSC-derived cell products promise to address current limitations by improving scalability, safety, and time-to-treatment. This Series paper examines the latest advancements in cell therapy, focussing on the European experience, while comparing global trends. We discuss challenges specific to Europe, such as regulatory frameworks, manufacturing scalability, and disparities in access. Emphasis is placed on emerging innovations like gene-edited and allogeneic therapies, as well as future directions for integrating cell therapies into mainstream oncology. We conclude with recommendations for overcoming barriers related to cost, toxicity management, and equitable access across Europe.