Access to CAR-T therapy in Latin America: Barriers, gaps, and pathways forward.

Abstract

Chimeric antigen receptor (CAR) T cell therapy has transformed the treatment of hematological malignancies, offering durable responses in conditions such as diffuse large cell lymphoma, B-cell leukemias and multiple myeloma. However, access to this therapy is still limited in low- and middle-income nations, especially those in Latin America. This review discusses the challenges to use CAR-T cell therapy in Latin America and explores potential ways to expand access to this treatment. We discuss the high cost of the treatments, the complex manufacturing and logistical requirements, and the insufficient infrastructure for safe administration and managing side effects. Socioeconomic and geographical differences further limit access. Moreover, the under representation of Latin Americans in clinical trials, along with the region's genetic diversity, limits our understanding about the effectiveness and safety in such populations. New approaches include decentralized, point-of-care manufacturing models. These have shown over 90% cost reduction in pilot programs, along with collaborative projects and innovative technology. Examples of innovative technology are allogenic off-the-shelf CAR-T products and mRNA-based approaches. These methods aim to cut production times, lower cost and improve tolerability. We conclude that achieving equitable CAR-T cell access in Latin America requires a multifaceted strategy: harmonized regulatory frameworks, scalable academic manufacturing, investments in infrastructure and integration of population-specific immunogenomic profiling. Scientific innovation combined with policy reform and regional collaboration can transform CAR-T cell therapy from a high-cost intervention into a sustainable treatment option for a diverse patient population.