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Anvisa authorizes clinical research with CAR-T cells in cancer treatment

The National Health Surveillance Agency (Anvisa) authorized a clinical trial in Brazil with a medicine based on genetically modified cells, or CAR-T cells, which could be an advance in the treatment against blood cancer.

The research must be carried out by the Fundação Hemocentro de Ribeirão Preto (FUNDHERP), in partnership with the Butantan Institute.

Treatment consists of reprogramming the patient’s own cells to attack and destroy the cancer.

The technique is being developed for people suffering from B acute lymphocytic leukemia and B non-Hodgkin lymphoma, in cases of disease reappearance or resistance to conventional treatment.

The studies are in the initial clinical phase and their safety and effectiveness will be evaluated, Anvisa reported.

According to the agency, approval “involves frequent reviews of research data and information, with actions planned until December 2024, to closely monitor product development.”

“If the results are good, the objective is to register the product quickly so that people have access to a safe, effective and high-quality treatment option available in the SUS,” stated the agency.

According to information from the Butantan Institute, the first Brazilian volunteer to receive an experimental treatment with CAR-T cells, in 2019, showed complete remission of a terminal-stage lymphoma.

This type of therapy, created in the United States, has been tested since 2010. In the United States, the positive results led to the approval of the treatment by the American Food and Drug Administration (FDA) in 2017.

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Source: CNN Brasil

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