The second gene therapy of lymphoma
On October 18, the US Food and Drug Administration (FDA) officially approved the clinical use of the Yescarta gene therapy method (axicabtagene ciloleucel), intended for the treatment of patients with certain types of large-cell B-cell lymphoma who did not respond or relapsed after using at least two other therapeutic protocols. Yescarta, which is a method of treatment with chimeric antigen receptor (CAR)-carrying T-lymphocytes, is the second gene therapy and the first gene therapy for certain types of non-Hodgkin lymphoma that has received FDA approval.
The diagnosis of "non-Hodgkin's lymphoma" includes a group of malignant diseases affecting certain cells of the immune system, which can be both rapidly progressive (aggressive) and with slow development. In the USA, 72,000 cases of non-Hodgkin's lymphoma are diagnosed annually, one in three of which is represented by diffuse B-large cell lymphoma. In addition to this disease, Yescarta therapy is approved for the treatment of primary mediastenal B-large cell lymphoma, highly differentiated B-cell lymphoma and diffuse B-large cell lymphoma developed from follicular lymphoma. At the same time, it should not be used for primary lymphoma of the central nervous system.
Each dose of Yescarta is a personalized drug made from the patient's own immune cells. To make the drug, the patient's T-lymphocytes are isolated and genetically modified. After that, the modified cells expressing CAR on their surface are injected into the patient's body, where they find and destroy tumor cells.
The safety and efficacy of Yescarta was confirmed in a multicenter clinical trial involving more than 100 adult patients with resistant or recurrent B-large cell lymphoma. The frequency of complete remission after treatment was 51%.
Treatment with Yescarta can cause severe side effects, such as cytokine release syndrome – a systemic reaction to the activation and proliferation of CAR-T cells, leading to a strong increase in body temperature and the development of flu-like symptoms – and neurological toxicity. Both conditions can be fatal or life-threatening. Other possible adverse reactions include serious infections, a decrease in the number of blood cells and a weakening of immunity. Side effects usually develop within 1-2 weeks after the use of therapy, however, some of them may be of a distant nature.
Taking into account the possibility of severe side effects, the use of Yescarta can only be carried out by specially trained personnel of certified clinics, after assessing the degree of risk and informing the patient about the possible development of adverse reactions and the need to urgently return to the clinic if appropriate symptoms appear.
To further assess the long-term safety of Yescarta, the FDA has ordered the manufacturer Kite Pharma to conduct a post-marketing observational study with the participation of patients who have undergone therapy.
Evgeniya Ryabtseva
Portal "Eternal youth" http://vechnayamolodost.ru According to the FDA: FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma.