The Food and Drug Administration (FDA) has approved the first gene therapy to treat children and young adults with leukemia."A person who has had a relapse in their leukemia, it's often very difficult to get them into remission or keep them in remission after relapse," said Jeffrey Hord, M.D., FAAP, past chair of the AAP Section on Hematology and Oncology and director of the Division of Hematology-Oncology at Akron Children's Hospital.Kymriah contains a boxed warning for cytokine release syndrome and has the potential for other severe side effects, including serious infections, low blood pressure, acute kidney injury, fever and decreased oxygen.is a chimeric antigen receptor T cell therapy in which a patient's T cells are collected and genetically modified to kill leukemia cells, according to the FDA."We're entering a new frontier in medical innovation with the ability to reprogram a patient's own cells to attack a deadly cancer," FDA Commissioner Scott Gottlieb, M.D. said in a news release.Each year, about 3,100 patients ages 20 and younger are diagnosed with acute lymphoblastic leukemia (ALL), a cancer of the bone marrow and blood.Kymriah from Novartis Pharmaceuticals Corp.