Ministry of Health requests review of CAR-T cell therapy for treating blood malignancies

On September 19, the Department of Science, Technology and Training, Ministry of Health sent an official dispatch to the Ho Chi Minh City Department of Health requesting a report on the Ho Chi Minh City Blood Transfusion and Hematology Hospital providing information on patients who successfully applied CAR-T cell therapy.

Tisagenlecleucel cell bags before being infused into patients - Photo: BVCC

Accordingly, the Department of Science, Technology and Training, Ministry of Health has received information from the mass media about the Ho Chi Minh City Hematology and Blood Transfusion Hospital sharing information about the first case in Vietnam successfully applying CAR-T cell therapy, bringing hope to many children with blood malignancies.

The Department said that the application of cells and cell products, including stem cells, in disease prevention and treatment requires scientific evidence of the safety and effectiveness of the method.

At the same time, it is necessary to comply with the provisions of the Law on Medical Examination and Treatment No. 15/2023/QH15, Decree No. 96/2023/ND-CP of the Government detailing and guiding the implementation of a number of articles of the Law on Medical Examination and Treatment and Circular No. 32/2023/TT-BYT of the Minister of Health detailing a number of articles of the Law on Medical Examination and Treatment.

To ensure the rights and safety of patients in Vietnam and compliance with current relevant legal regulations, the Department of Science , Technology and Training requests the Ho Chi Minh City Department of Health to urgently review and verify the information that the Ho Chi Minh City Blood Transfusion and Hematology Hospital has provided to the media about the use of CAR-T cell therapy by patients in Vietnam.

It provides the legality of the CAR-T cell therapy the patient used (whether the therapy has been licensed for application in medical examination and treatment or not), the protocols and procedures at the hospital for patients using CAR-T cell therapy.

At the same time, review the regulations for controlling and approving the content of information provided to the media about the hospital's CAR-T cell therapy to ensure complete and accurate information.

The Ho Chi Minh City Department of Health must report the above contents to the Ministry of Health (Department of Science, Technology and Training, Department of Legal Affairs, Department of Medical Examination and Treatment Management) before September 25, as a basis for reporting to the ministry's leaders.

The Ho Chi Minh City Blood Transfusion and Hematology Hospital said it is the pioneer in implementing this technique, in collaboration with foreign partners. So far, two cases have been applied, one of which was successful.

The successful treatment was a 12-year-old female patient diagnosed with B-cell acute lymphoblastic leukemia, high-risk group. After the first bone marrow relapse after chemotherapy, the patient received a half-matched bone marrow transplant from her father but still relapsed a second time.

The patient was then treated with CAR-T cell therapy using the drug Kymriah. To date, after more than a year of treatment, the patient is still healthy, living a normal life and is being monitored and treated.

Regarding the process of infusing CAR-T cells using Kymriah drug for children, it was carried out in Taiwan (China), because the cost was lower than other countries in the region and there was professional cooperation. However, the treatment cost was still very high, estimated at tens of billions of VND.

"This is the first case of a Vietnamese patient using Tisagenlecleucel (a product approved by the US Food and Drug Administration - FDA for the treatment of patients with relapsed acute lymphoblastic leukemia in 2017)," the hospital stated.

What is CAR-T cell therapy?

CAR-T cells are being promoted in many developed countries, and Tisagenlecleucel is one of the FDA-approved preparations for the treatment of patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

These are the first steps on the path to help Vietnamese patients access new, modern treatment methods, opening up many survival opportunities for patients who have had poor response to previous classical treatments, and at the same time marking a step forward in the international cooperation environment in the field of treating malignant diseases.

LINH HAN - BINH NGHI

Source: https://tuoitre.vn/bo-y-te-yeu-cau-ra-soat-lieu-phap-car-t-cell-dieu-tri-benh-ac-tinh-ve-mau-20250919193013005.htm