Brazil approves third gene therapy product to treat cancer

Brazil`s national drug regulator Anvisa has approved the sanitary registration of the third gene therapy product for cancer treatment. Yescarta® (axicabtagene ciloleucel), manufactured by Gilead Sciences Farmacêutica do Brasil, is intended for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (DLBCL).

Therapy with genetically modified cells has demonstrated a safety and efficacy profile in the treatment of relapsed and refractory patients for severe lymphomas. "The approved product is composed of autologous T cells with chimeric antigen receptor (CAR), designed to eliminate tumor cells expressing CD19," Anvisa explains

Special care

According to Anvisa, the main safety concern involving the product is cytokine release syndrome (CRS), a systemic response to the activation and proliferation of CAR-T cells, which causes high fever and flu-like symptoms, infections, and encephalopathy or brain disorder.

The strategies for monitoring and mitigating these effects are a fundamental part of the risk management plan defined in the registration process, with accountability measures that include the training of professionals involved in the handling of the product; and the specific qualification for health services that will collect and handle the starting material, Anvisa informed.