"The Food and Drug Administration approved a second version of a groundbreaking treatment Wednesday that genetically alters patients cells to attack cancer  this time to fight aggressive nonHodgkin lymphoma. The treatment is for adults with certain types of large Bcell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment such as chemotherapy and bonemarrow transplants. The group numbers about  patients a year in the United States. The onetime infusion known as CAR Tcell therapy is made by Kite Pharma which is based in Santa Monica Calif. and recently was bought https_term.fbda by Gilead Sciences for . billion. Kite announced Wednesday that the treatments brand name will be Yescarta and its price will be . In late August the FDA cleared https_term.efccb the first CAR Tcell therapy which is designed for children and young adults whose leukemia doesnt respond to standard treatments. About  patients in the United States fall into that category every year. Kymriah which costs  is manufactured by Novartis. Biotech analysts had expected the Kite price to be lower than Kymriahs in part because the number of eligible patients is larger and the response rates are lower. Even so Yescartas cost is likely to stoke the ongoing debate about high drug prices.  The FDA approval is the latest step forward for the fastmoving field of immunotherapy which aims to bolster the immune system to attack malignancies. CAR Tcell therapies are among several approaches along with treatments called checkpoint inhibitors https_story.htmlutm_term.bdfd and cancer vaccines but they have recently grabbed much of the attention. Dozens of other companies also are working on them. Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases FDA Commissioner Scott Gottlieb said in a statement adding that the approval demonstrates the continued momentum of this promising new area of medicine. A CAR Tcell therapy involves a complicated and customized procedure in which T cells  sometimes called the foot soldiers of the immune system  are removed from the patient. They are sent to a special lab and genetically modified  to target a protein on the surface of the patients cancer cells. Once the modified cells are returned to the patient their numbers expand exponentially as they become an army of cancer fighters. In  Marie Miceli was diagnosed with nonHodgkin lymphoma at Siteman Cancer Center in St. Louis which is jointly owned by BarnesJewish Hospital and Washington University School of Medicine. She received chemo and underwent a bonemarrow transplant. Neither worked. The doctors were saying Go see an attorney and get your life in order  the yearold Realtor recalled. Then they offered her a slot in Kites clinical trial a lastresort effort. I could feel it when they put those T cells back in she said. It was the craziest feeling in the world. When she was checked a month later she said her cancer was gone. It hasnt returned. Kites veintovein turnaround period  from cell extraction to reinfusion  is about  days according to Frederick Locke an oncologist at Moffitt Cancer Center in Tampa and coleader of the Kite trial. The FDA said the safety and efficacy of Yescarta were established in a multicenter trial of more than  adults with large Bcell lymphoma. An independent review committee found that  percent of patients treated with a single infusion responded to therapy including  percent who then showed no evidence of remaining cancer. Kite has said that at six months  percent of patients were still responding with  percent having no sign of cancer. This is not just an incremental benefit said David Chang Kites chief medical officer. It raises the potential that a cure can be possible. Some of the first patients who underwent treatment now have been in remission for three to five years he said although he cautioned that its still too early to know whether those patients are cured. Locke said about  percent of patients in the trial had a severe side effect https_term.ecdaca known as cytokine release syndrome which produces high fevers low blood pressure and other flulike symptoms. Twentyeight percent had neurological events such as severe confusion three patients died of complications caused by the treatment. These are patients who knew they were out of options he said noting that lymphoma patients who relapse or dont respond to treatment have just a  percent chance of surviving for six months. Because of the side effects the treatment will carry a boxed warning the FDAs most serious. In addition the agency is requiring hospitals and clinics that dispense Yescarta to be certified after undergoing special training. Diffuse large Bcell lymphoma is the most common type of nonHodgkin lymphoma in adults. This type of cancer begins in the immune system and can be fast or slowgrowing the FDA noted.  Kites CAR Tcell product was developed years ago at the National Cancer Institute by pioneering scientist Steven Rosenberg and licensed to the company for commercialization. Armin Ghobadi an oncologist at Siteman who was an investigator in the Kite trial said the new treatment is just the first step and that researchers are working to make it safer and more effective. He said the therapy already has been lifechanging for many of his patients  and for him. Theres nothing worse than telling patients Im sorry we are done here we dont have anything else to offer  he said."