Cofepris authorizes the importation of an innovative treatment against blood cancer

In an unprecedented event for the health system in Mexico, the Federal Commission for the Protection against Health Risks (cofepris) issued the first permit for the importation of a lentiviral vector. It is a treatment based on the use of CAR-T cells in patients with blood cancer and that it will undergo a clinical investigation process to assess its use in patients nationwide.

As they announced, the treatment can be implemented in pediatric patients or young adults with no response or relapse despite chemotherapy. It should be mentioned that various clinical trials have shown high rates of effectiveness in improving the health of people with conditions such as leukemia, lymphoma or myeloma.

“Usually it’s a therapy for non-responder patients without curative options with conventional treatments, providing a new opportunity for disease remission,” authorities said in the statement.

On its official website, the health regulatory body confirmed that the import permit had been granted to the University Hospital “Dr. José Eleuterio Gonzalez” from the Autonomous University of Nuevo León (UANL). In this sense, in said educational entity, preliminary phases will be implemented in the laboratory to begin the clinical trial with T cell therapy with chimeric receptors (CAR-T, for its acronym in English).

CAR-T cell therapy envisions a treatment that aims to extract and modify T cells from patients suffering from blood cancer. The goal is the selective destruction of cells that promote disease development.

It consists of taking the patient’s blood in order to locate and isolate the T cells, one of the most important components of the immune system. Subsequently, specialists carry out the modification of said blood component in the laboratory to create CAR-T cells by inserting a gene.

The next step consists of the mass reproduction of millions of CAR-T cells in the laboratory so that they can be injected back into the bloodstream of patients. As a result, modified T cells can unite with malignant cells to destroy them and improve people’s health.

It should be mentioned that the specialists of the Faculty of Medicine (Facme) of the National Autonomous University of Mexico (UNAM), who specialize in research on the subject, assured that “it has been used considerably in recent years, obtain very favorable results in patients with refractory tumours.

“If the clinical phases are completed, UANL will be the first public institution in the country to have this cutting-edge therapeutic alternative. During a meeting with CHU authorities, Cofepris specialists confirmed that they will provide regulatory support for the design of the research protocol through technical sessions,” Cofepris authorities wrote.

On the other hand, Cofepris has announced that in the coming weeks a working group will meet to will regulate various advanced therapies including that of CAR-T cells. In this way, Mexican patients will be able to count on a wider range of therapeutic alternatives for their implementation in a safe, effective and quality way.

Due to the effectiveness that the use of CAR T cells has shown in patients with blood cancers, the National Cancer Institute in the United States has reported that various institutions have implemented studies to bring the treatment to d other types of cancer.

As indicated by INEGI in 2022, between 2010 and 2020 the rate of cancer-related deaths increased from 6.18 to 7.17 per 10,000 population. In this sense, the implementation of the treatment and its investigation could contribute to reducing the number of them in the future.