FDA approves gene-therapy treatment for leukemia

The Food and Drug Administration (FDA) approved a breakthrough treatment for leukemia Wednesday. Kymriah is the first-ever cell-based gene therapy for cancer. “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 said. After years of clinical trials, the FDA approved Kymriah for patients 25 and younger suffering from a form of acute lymphoblastic leukemia that has not responded to other treatments. Kymriah involves removing immune system cells, reengineering the cells in a laboratory to target the cancer, and infusing them back into the patient. In clinical trials, Kymriah treated 63 patients, and 83 percent went into remission within the first three months. Initially, 32 U.S. hospitals and clinics will administer the gene therapy. The one-time treatment for qualified patients will cost $475,000.