‘Most Exciting Thing I’ve Seen In My Lifetime’: FDA Panel Approves Groundbreaking Cancer Treatment

The New York Times: F.D.A. Panel Recommends Approval For Gene-Altering Leukemia Treatment
A Food and Drug Administration panel opened a new era in medicine on Wednesday, unanimously recommending that the agency approve the first-ever treatment that genetically alters a patient’s own cells to fight cancer, transforming them into what scientists call “a living drug” that powerfully bolsters the immune system to shut down the disease. (Grady, 7/12)

The Washington Post: FDA Panel Recommends Approval Of CAR T-Cell Therapy
The unanimous recommendation from the Oncologic Drugs Advisory Committee means the treatment could be approved by the FDA by the end of September, forging a new path in the immunotherapy frontier. Timothy Cripe, a panel member who is an oncologist with Nationwide Children's Hospital in Columbus, Ohio, called the treatment the "most exciting thing I've seen in my lifetime." (McGinley, 7/12)

NPR: FDA Advisors Endorse Genetically Engineered Immunotherapy For Cancer
The treatment takes cells from a patient's body, modifies the genes, and then reinfuses those modified cells back into the person who has cancer. If the agency approves, it would mark the first time the FDA has approved anything considered to be a "gene therapy product." The treatment is part of one of the most important developments in cancer research in decades — finding ways to harness the body's own immune system to fight cancer. (Stein, 7/12)

The Fiscal Times: Groundbreaking New Leukemia Treatment Will Save Lives And Billions
An advisory panel of the FDA voted 10-0 to recommend the approval of tisagenlecleucel, a treatment developed by the pharmaceutical firm Novartis. The treatment requires the extraction of a patient’s own infection-fighting T-cells, which are then genetically engineered to recognize and fight the cancer cells affecting the patient, and infused back into the bloodstream. (Garver, 7/12)