The National Health Surveillance Agency (Anvisa) approved, this Wednesday (23), the first health record in the country of advanced treatment for hematological cancer. The product of the company Novartis is a gene therapy based on chimeric antigen receptor (CAR) T cells, the so-called “CAR-T cells”.
Kymriah (tisagenlecleucel) is part of a new generation of personalized cancer immunotherapies, which are based on the collection and genetic modification of patients’ own immune cells.
The patient’s T cells are collected at the health facility and sent to a manufacturing center, where they are genetically modified to include a new gene that contains a specific protein (a chimeric antigen receptor, or CAR).
It is precisely this protein that directs T cells to kill cancer cells that have a specific antigen (CD19) on their surface. After being modified in the laboratory, the cells are cultivated and formulated into a pharmaceutical suspension to compose the product that will be applied to the patient.
The product approved by Anvisa is indicated for the treatment of pediatric patients and young adults (up to 25 years of age) with refractory B-cell Acute Lymphoblastic Leukemia (ALL) or from the second relapse. The treatment is also indicated for adult patients with recurrent or refractory Diffuse Large B-Cell Lymphoma (LDGCB) after two or more lines of systemic therapy.
The product has also been approved by other regulatory authorities, such as the Food and Drug Administration (FDA) in the United States; the European Medicines Agency (EMA) in Europe; and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.
Evaluation process
According to Anvisa, the analyzes made showed that the complex process of production, transport, administration and post-use monitoring of the product is safe and promotes the intended effectiveness. The benefits of tisagenlecleucel were considered to outweigh its risks.
There were 268 consecutive days of evaluation, from the submission of documents by Novartis to Anvisa until the publication of the registration, considering the deadlines for analysis by the agency’s professionals and the responses to the company’s compliance with the requirements.
Source: CNN Brasil
