Terapia CAR-T: avanços e perspectivas no Brasil

Abstract

CAR-T cell therapy (Chimeric Antigen Receptor T-cell therapy) represents one of the most advanced immunotherapy strategies in the treatment of hematological malignancies. This study aimed to list the drugs approved by ANVISA (Brazilian Health Regulatory Agency) for CAR-T therapy in Brazil, discuss their main therapeutic targets, analyze the progress and future prospects of the therapy in the country, identify its main obstacles, and clarify the eligibility criteria for patients and access to treatment. This is an integrative narrative review, conducted in the PubMed, SciELO Brazil, LILACS, and CAPES Periodicals databases, supplemented by institutional documents, regulatory reports, and official clinical trial records. The systematic search did not identify original articles with complete clinical results published in Brazil, due to the fact that the first national clinical trial, the CARTHEDRALL Study (NCT06101381), is still ongoing. The materials found include reviews, institutional communications, and technical updates from organizations such as ANVISA, INCA, Instituto Butantan, Fundação Hemocentro de Ribeirão Preto, and FIOCRUZ. The results indicate that Brazil is advancing in the production and clinical application of the therapy, with national experimental platforms and a growing laboratory infrastructure. However, challenges persist, such as the absence of fully consolidated regulatory frameworks, high costs, production complexity, and limited patient access. It is concluded that the country possesses increasing scientific and technological capacity to consolidate CAR-T therapy, provided there is a strengthening of public policies, expansion of research, and integration between health centers, universities, and regulatory bodies, enabling this innovative technology to become accessible and sustainable within the Unified Health System (SUS).