The Food and Drug Administration approved another immunotherapy known as Yescarta on Wednesday. It is a form of gene therapy that could treat people who are diagnosed with a deadly form of blood cancer called non-Hodgkin's lymphoma.
FDA Commissioner Scott Gottlieb said that this marks another milestone in the development of a whole new scientific paradigm for the treatment of serious disease. He further said that the approval shows the "continued momentum of this promising new area of medicine."
Meanwhile, Dr. Frederick L. Locke, a specialist in blood cancers at the Moffitt Cancer Center in Tampa and lead author of the study of the new treatment describes the results as remarkable. They are also excited and think that many patients may need this therapy.
New York Times reports that about 3,500 people a year in the United States will be needing the Yescarta, which is developed by Kite Pharma. The treatment is to be given once and infused into a vein. It must also be made individually for every patient for a cost of $373,000.
Yescarta was trialed in 101 patients who had one of these three diseases namely the diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma and the transformed follicular lymphoma. The results showed that about 54 percent of patients had a complete remission, in which their tumors disappeared. About 28 percent had partial remissions meaning the patients' tumors shrank or became less active. And about 80 percent of them were still alive after six months.
The process of treatment requires removing millions of T-cells, which is a type of white blood cell, in the patient's body. They are frozen and sent to Kite Pharma to be genetically engineered to destroy cancer cells.Kite Pharma could provide the new treatment for 4,000 to 5,000 patients in a year. It also applied for approval in Europe as of today. Meanwhile, FDA also approved the first CAR T-cell therapy to treat people who have leukemia in August.
Non-Hodgkin's lymphoma also referred to as lymphoma is cancer that affects and originates in white blood cells known as lymphocytes. These are part of the body's immune system in which the tumors are developed. Its symptoms include abdominal pain or swelling, swollen lymph nodes in your neck, armpits or groin, fever, fatigue, weight loss, chest pain, coughing, trouble breathing, and night sweats, according to Mayo Clinic.
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