Second Version Of Groundbreaking Immunotherapy Treatment Approved By FDA
The therapy is part of a hot new field that uses a patient's own immune system to turn the cells into a "living drug" that attacks disease.
The New York Times:
F.D.A. Approves Second Gene-Altering Treatment For Cancer
The Food and Drug Administration on Wednesday approved the second in a radically new class of treatments that genetically reboot a patient’s own immune cells to kill cancer. The new therapy, Yescarta, made by Kite Pharma, was approved for adults with aggressive forms of a blood cancer, non-Hodgkin’s lymphoma, who have undergone two regimens of chemotherapy that failed. (Grady, 10/18)
The Washington Post:
Cutting-Edge Immunotherapy Treatment Approved For Another Deadly Cancer
The treatment is for adults with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment, such as chemotherapy and bone-marrow transplants. The group numbers about 7,500 patients a year in the United States.The one-time infusion, known as CAR T-cell therapy, is made by Kite Pharma, which is based in Santa Monica, Calif., and recently was bought by Gilead Sciences for $11.9 billion. Kite announced Wednesday that the treatment's brand name will be Yescarta and its price will be $373,000. (McGinley, 10/18)
Stat:
FDA Approves A Game-Changing Treatment For Blood Cancer
In a six-month trial on 101 patients, 36 percent saw their cancer completely disappear thanks to a single dose of Gilead’s therapy, and 82 percent had their tumors shrink by at least half. But the treatment is not without risks. More than 40 percent of patients suffered anemia during the trial, and common side effects include a dangerous lowering of white blood cell counts and toxicity in the brain. Two patients in the study died of treatment-related complications. (Garde, 10/18)