Hospital Israelita Albert Einstein announced that it had received, last Friday (9), approval from the National Health Surveillance Agency (Anvisa) to process CAR-T cells in the treatment of patients with B-cell lymphomas and acute or chronic B-lymphocytic leukemias. , in cases of reappearance of the disease or in situations of resistance to standard treatment.
The expectation is that ten people, from a group of 30 patients from the Unified Health System (SUS), within the Proadi-SUS project —partnership between the Ministry of Health and six reference hospitals for research—, start receiving treatment. in one or two months.
In this type of treatment, the T cells, which act in the body’s defense, are removed from the blood and genetically altered so that they fit on the surface of the cancerous particles and can attack them. The material is multiplied in the laboratory and reinserted into the patient.
In other words, the technique used consists of genetically reprogramming cells of the patient’s own defense system, in the case of T lymphocytes, to recognize and fight their tumor.
“The size of this approval is enormous because it is the first time it has taken place for an academic project”, says Nelson Hamerschlak, hematologist, coordinator of the Hematology and Bone Marrow Transplantation Program at Einstein. “It was a very nice surprise.”
Currently, the material collected, recalls Hamerschlak, needs to be sent to pharmaceutical laboratories in the United States, where the cells are genetically altered. And they will only be reimplanted between three to four months later, says the doctor. During this period, the patient undergoes intermediate treatments.
With the “nationalization” of the bedside procedure, the expectation is that the genetically modified cells will be reimplanted in the patient within 12 days.
According to him, it took between two and three years of work by a team of more than ten people so that the project could fulfill all the requirements demanded by the health agency.
Questioned early this Sunday afternoon (10) about the approval, Anvisa did not respond until the publication of this report.
Another advantage, says the expert, is the reduction of approximately 90% in expenses in relation to the internationalized operation. According to Hamerschlak, the procedure currently costs between US$ 350 thousand (R$ 1.84 million) and US$ 450 thousand (R$ 2.37 million). “You can drop to as low as $30,000 [R$ 158 mil]”,
“This will allow the procedure to be more widely used in a country like ours, especially for SUS patients”, he says.
Last month, the state government launched a cellular technology-based cancer treatment program with an estimated 300 patients seen each year.
The government program is the result of a study being carried out between the Butantan Institute, USP (University of São Paulo) and the Ribeirão Preto Blood Center, in the interior of São Paulo.
During the presentation of the project, Dimas Covas, president of Butantan, stressed the possibility of cure with cell therapy, which the Einstein specialist reinforces.
Hamerschlak says that the result of treatment in acute leukemias “that have not responded to anything”, can reach more than 80% cure. “And that in lymphomas can reach around 50%. It’s an important procedure”, he says.
The clinical study had the participation of several fronts of the hospital, such as the area of ​​Hemotherapy and Cell Therapy, the Bone Marrow Transplantation Unit, the Instituto Israelita de Ensino e Pesquisa and the Academic Research Organization (ARO), from Eintein itself.
The first people will start to be treated from the arrival of inputs, which will be produced from the release of Anivsa.
For the hematologist, the trend is for this type of treatment to grow a lot. He recalls that there are studies for the use of donor cells. “This could be on a ‘shelf’ for use.”
There is also research to fight other types of cancer, such as pediatric and breast tumors with the CAR-T cell process.
cellular technology
Cell therapy was developed in the United States about five years ago. There, clinical studies receive patients from both local and foreign countries. In March 2021, the FDA (US regulatory agency) approved the use of this technology in people with multiple myeloma, a type of cancer that starts in the bone marrow.
The first record approved by Anivsa for the therapy, but aimed at the private sector, was last February. The authorization was given to the company Novartis Biociências. In April, the release was finally given to Janssen-Cilag Farmacêutica.
In Brazil, the technique is used so far only experimentally. It was tested for the first time in the country in Ribeirão Preto, 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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