Anvisa monitors the development of studies on advanced therapies

The development of treatment with CAR-T cells was the subject of a meeting between the National Health Surveillance Agency (Anvisa), the Butantan Institute and the Blood Center of Ribeirão Preto, in the interior of São Paulo. In this form of treatment, the patient’s T cells (a type of immune system cell) are altered in the laboratory to recognize and attack cancer or tumor cells. The term CAR refers to a chimeric antigen receptor. According to Anvisa, the meeting was positive for consolidating technical understandings and actions to enable authorization to conduct clinical studies in Brazil. In a note, the agency says that it has been monitoring the project with priority so that the clinical study can start soon, focusing on the future registration of the treatment in the country. According to Anvisa, the product’s preclinical and clinical protocols with CAR-T cells are in the process of being improved. In March 2023, following the submission of initial documentation for the study, the agency requested additional clarification on specific preclinical safety trial requirements, issues related to the proposed clinical trial design, and necessary safety assessments. applicants about their availability for clarification and follow-up meetings. “Anvisa innovated and made available the regulatory technical cooperation pilot project for the development of advanced therapy products (APTs) of interest to the Unified Health System (SUS). The Butantan Institute and the Ribeirão Preto Blood Center were approved by the call notice, which aims to select national developers to participate in this pilot project”, says the agency. According to Anvisa, new meetings will be held for the technical evaluation of points necessary for the start of clinical studies with volunteers. “Despite the positive news, we clarify that studies need to be conducted and have results capable of confirming the efficacy and safety, allowing the registration and expansion of access to this therapy”. Anvisa emphasized that the use of such therapy occurs experimentally for specific patients and under the supervision of a physician. At this time, the procedure does not yet qualify as a clinical trial.

Agência Brasil