- The use of CAR-T cells is the biggest innovation in the treatment of hematological cancers such as leukemia and lymphoma.
- Cofepris is the first Spanish-speaking regulatory agency to authorize this therapeutic alternative.
- The permit was granted to the University Hospital “Dr. José Eleuterio González” from the Autonomous University of Nuevo León.
In a historic event, the Federal Commission for the Protection Against Sanitary Risks (Cofepris) issued the first import permit for a lentiviral vector in Mexico. With this, the University Hospital “Dr. José Eleuterio González” from the Autonomous University of Nuevo León (UANL) will begin the clinical research process on the effects of the use of CAR-T cells. It’s about a novel treatment for patients with leukemia.
This university, with a teaching hospital that is the only one of its kind, is working in the preliminary laboratory phases for the development of a clinical trial to test the safety of T-cell therapy with chimeric antigen receptors (CAR-T therapy for its acronym in Spanish). in English) in people with lymphoblastic leukemia.
In this type of gene therapy, the immune cells of patients with hematological malignancies such as leukemia, lymphoma or myeloma. They are genetically modified to selectively recognize, attack and destroy malignant cells.
Who can access this treatment against leukemia?
It is a new treatment option for pediatric and young adult patients who have failed or relapsed despite chemotherapy or hematopoietic cell transplantation. It is generally a therapy for patients who do not respond and have no curative options with conventional treatments, offering a new opportunity for disease remission.
If the clinical phases are completed successfully, the UANL will be the first public institution in the country to have this advanced therapeutic alternative. In a meeting with authorities from the University Hospital, specialists from Cofepris confirmed that they will provide regulatory support to the design of the research protocol through technical sessions.
This milestone responds to the commitment of the Mexican health agency to be an active promoter in the development of national science through direct work with the country’s public research centers.
New treatment option against leukemia in Mexico
In line with the above, Cofepris will start a working group in the coming weeks to build the regulation of advanced therapies, including gene therapies such as those that use CAR-T cells. The foregoing with the purpose of allowing Mexican patients to have safe, effective and quality access to these therapeutic alternatives.
This regulatory authority has as one of its guiding principles the promotion of innovation in health services and clinical research, prioritizing the public interest at all times through proactive regulatory actions.
With the delivery of this permit to the UANL, Mexico, from a public academic institution, takes the first step for the use of CAR-T cells with the purpose of providing innovative therapies to cancer patients.
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