The National Health Surveillance Agency (Anvisa) approved the performance of the first clinical trial for the national development of a gene therapy product based on genetically modified cells, called CAR-T, for the treatment of cancer. The clinical research will be carried out by Hospital Israelita Albert Einstein, in São Paulo, with funding from the Unified Health System (SUS).
The technology, which genetically reprograms cells of the individual’s own defense system to recognize and fight the tumor, is used in patients with B-cell lymphomas, in cases of reappearance of the disease or resistance to standard cancer treatment.
In this first phase of the research, few patients should participate in the clinical trial. All steps will be strictly controlled for the assessment of risks and benefits.
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Importance of approval
“The size of this approval is huge because it is the first time for an academic project. It was a very good surprise”, said Nelson Hamerschlak, hematologist, coordinator of Einstein’s Hematology and Bone Marrow Transplantation Program, in an interview with the Oncoguia portal.
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.
Currently, the material collected 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. During this period, the patient undergoes intermediate treatments.
of the entire procedure in Brazil, the expectation is that the genetically modified cells will be reimplanted in the patient within twelve days.
According to Nelson Hamerschlak, it took two to three years of work by a team of more than ten people for the project to fulfill all the requirements demanded by the health agency.
Another advantage is the reduction of around 90% in expenses compared to the internationalized operation . Currently, the procedure costs between US$ 350 thousand (R$ 1.84 million) and US$ 450 thousand (R$ 2.37 million).
“The forecast is to drop to up to US$ 30 thousand, that is, R$ 158 thousand. This will allow the procedure to be more widely used in a country like ours, especially for SUS patients”, stated Nelson Hamerschlak.
Last month, the government of São Paulo launched a program for cancer treatment based on cellular technology, with an estimate that up to 300 patients are treated per year.
During the presentation of the project, the president of the Butantan Institute, Dimas Covas, stressed the possibility cure with cell therapy, which in acute leukemias can reach more than 80% cure. And in lymphomas it can reach around 50%.
Over 18 clinical trials with advanced therapy products have been authorized by Anvisa since 2018. These products are a special category of innovative medicines that comprise advanced cell therapy products, tissue engineering products and gene therapy products.
*This article was reviewed by the medical team of the PEBMED Portal.
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Journalist graduated from Universidade Estácio de Sá (UNESA), post-graduated in Communication with the Market from Escola Superior de Propaganda e Marketing (ESPM) and in Strategic Communication Management from Instituto de Gestão e Communication (IGEC/FACHA)
# Authorized national research with CAR-T cells to treat cancer. Ministry of Health. Available at: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2022/autorizada-pesquisa-nacional-com-celulas-car-t-para-tratar-cancer-1 # Anvisa authorizes national research with CAR-T cells to treat cancer. Brazil Agency. Available at: https://agenciabrasil.ebc.com.br/saude/noticia/2022-07/anvisa-autoriza-pesquisa-nacional-com-celulas-car-t-para-tratar-cancer # Einstein is authorized to sue CAR-T cells for cancer treatment. oncoguide. Available at: http://www.oncoguia.org.br/conteudo/einstein-e-autorizado-a-processar-celulas-cart-para-tratamento-de-cancer/15489/7/