Anvisa approves therapy that changes patient cells to fight cancer

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Anvisa (National Health Surveillance Agency) approved the first health registration in Brazil of gene therapy with CAR-T cells, which modifies patient cells to fight cancer.

The so-called cell therapy is developed by the company Novartis Biosciences and may become an alternative to treat hematological cancer, such as leukemia.

The indication is for pediatric and adult patients up to 25 years of age with leukemia who have undergone other treatments and have not improved. And also for adult patients with lymphoma who have already undergone two or more lines of therapy.

Known as CAR-T cell therapy, the technique considers the molecular characteristics of each type of cancer to design a specific response against the disease.

T cells, which act in the body’s defense, are taken from the blood and genetically altered so that they fit on the surface of cancer particles and can attack them. The material is multiplied in the laboratory and reinserted into the patient.

Anvisa added that, to ensure the regularization of Kymriah in Brazil, there were numerous meetings, technical discussions and agreements between Anvisa and Novartis representatives in Brazil and abroad.

This is because it is the first time that Anvisa has registered an advanced therapy product that involves the use of starting material from the patient (T cells), which is exported for manufacture in the United States and returned (in the form of the CAR-T product) for inoculation into the patient in specific hospitals.

“The CAR-T cell-based product is a pioneering technological approach to treatment that meets the unmet need for other treatments in patients with severe cancer. It is a new option where alternatives are very limited, with promising remission and survival rates in clinical trials evaluated by Anvisa”, said the regulatory agency in a note.

The product has also been approved by other regulatory authorities, such as the FDA (Food and Drug Administration) in the United States; the EMA (European Medicines Agency), in Europe; and the Pharmaceuticals and Medical Devices Agency in Japan.

CAR-T cell therapy was developed in the United States. There, clinical studies receive patients from both local and foreign countries. In March 2021, the FDA approved the use of this technology in people with multiple myeloma, a type of cancer that starts in the bone marrow.

In Brazil, the technique is used so far only experimentally. It was tested for the first time in Brazil in Ribeirão Preto (São Paulo countryside), in 2019, at the USP School of Medicine. The patient was Vamberto Luiz de Castro, 62 years old at the time, diagnosed with B-cell non-Hodgkin’s lymphoma.

The approach showed promising results in the patient, who was terminally ill. However, doctors were unable to follow Vamberto’s condition long-term. The retiree died two months after treatment, as a result of a domestic accident.

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