National research with CAR-T cells is authorized by Anvisa
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 CAR-T cells for the treatment of cancer. The technology is used in patients with B-cell lymphomas, in cases of recurrence of the disease or resistance to standard treatment. It genetically reprograms cells of the individual's own defense system to recognize and fight the tumor.
The clinical research, according to Anvisa, will be carried out by Hospital Israelita Albert Einstein, with funding from the Unified Health System (SUS). The Agency points out that at first, the study will be carried out with few patient
The studies
Research or clinical trials are studies carried out with humans and whose objective is to discover or confirm clinical and therapeutic effects, identify adverse events and analyze characteristics and mechanisms of action, metabolism and excretion of a product or drug, in order to verify its safety, efficacy. and quality.
The trials are divided into several stages of development, according to the number of participants and the specific objectives of each stage. In Brazil, clinical trials with advanced therapy products (special category of innovative drugs) must be authorized and monitored by Anvisa.
Since 2018, the Agency has authorized more than 18 clinical trials with advanced therapy products, where drugs and products are developed from human cells and genes with the promise of meeting therapeutic and quality of life demands in rare diseases.
