Brazil’s Health Regulator approves first gene therapy against cancer

RIO DE JANEIRO, BRAZIL – The Brazilian Health Regulatory Agency (ANVISA) has for the first time approved a product used in a specific type of therapy for blood-related cancers (hematological), such as leukemia, lymphoma and myeloma.

The product is designed for people up to 25 years of age with certain types of Acute Lymphoblastic Leukemia, as well as for adult patients with specific types of Lymphoma.

According to ANVISA, this is a pioneering treatment. The agency’s technical team concluded that the product meets the minimum requirements in terms of safety and efficacy.

Novartis’ Kymriah can be employed in the treatment of these types of tumor by using the so-called CAR-T cells. According to the agency, this type of treatment works by collecting and altering patients’ immune cells.

In this approach, the patient’s cells are collected and altered to include a new gene. This gene contains a protein that directs so-called T-cells to act against tumor cells. After the alteration, these cells are then incorporated into the substance to be applied to the patient.

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