Amman - The Jordan Food and Drug Administration (JFDA) has approved a pioneering clinical trial, the first of its kind in the Kingdom, to treat patients diagnosed with relapsed or refractory acute lymphoblastic leukemia in children and adults, and relapsed or refractory lymphoma in adults, using Chimeric Antigen Receptor T-cell (CAR-T) therapy.
اضافة اعلان
According to a statement released on Tuesday, the JFDA's Director General, Dr. Nizar Mheidat, noted that the trial was submitted by the Royal Medical Services (RMS) and will be conducted at their facilities. He emphasized that CAR-T therapy is a promising immunotherapy treatment for cancer patients with limited options, involving genetic modification of T-cells to enhance the immune system’s ability to detect and eliminate certain cancers.
This innovative treatment marks a significant medical advancement and a major shift in the future of cancer therapy for patients who no longer respond to traditional methods such as chemotherapy, radiation, immunotherapy, and stem cell transplants.
Dr. Mheidat explained that the clinical trial underwent rigorous technical evaluation by a specialized committee from the JFDA, which included experts from the academic and medical sectors. The trial will be conducted at the Military Oncology Center, which has been approved to develop, produce, and modify these specialized T-cells in a laboratory environment that meets global Good Manufacturing Practice (GMP) standards. The JFDA, in collaboration with the Royal Medical Services, has ensured that the lab meets all requirements to safely produce this type of therapy.
The JFDA is the sole regulatory body responsible for approving and overseeing pharmaceutical studies in Jordan. It provides a robust regulatory framework to ensure the success of such trials, adhering to local legislation and the highest international standards. The administration continues to stay abreast of the latest global developments in treating critical diseases like cancer and aims to make cutting-edge treatments accessible to patients in Jordan.
This type of therapy has been implemented in only a limited number of centers worldwide, positioning Jordan among the leading countries in this advanced medical field. The approval of this trial also represents a significant addition to specialized medical care in the country, reducing the financial, social, and health burdens associated with sending patients abroad for treatment.
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