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Handout Carl June pioneered the therapy at Penn.The technology behind Novartis’ personalized drug, called Kymriah, or tisagenlecleucel, was developed at the University of Pennsylvania by a team led by gene therapy pioneer Carl June. Each patient’s immune system T cells are removed, programmed to attack acute lymphoblastic leukemia cells, then returned to the patient.The therapy showed unparalleled effectiveness, putting more than 80 percent of goyard replica terminally ill youths into remission in clinical tests at Children’s Hospital of Philadelphia beginning in 2012, and in a pivotal study of 68 children at 25 medical centers around the world.”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 in a news release. “New technologies such as gene and cell therapies hold out the potential to transform medicine.”Novartis announced a hefty price tag $475,000 for the onetime treatment but said it is working with private insurers and the federal Centers for Medicaid and Medicare to develop a novel payment policy based on patient outcomes.”There will be no charge for the therapy if the patient doesn’t respond within the first month after treatment,” Novartis CEO Joseph Jimenez said during a media call.Whether the therapy works or not,patients’ insurance will have to cover the costs of the lengthy hospitalization involved in preparing for, and recovering from, the T cell therapy.The company also said it will help uninsured patients get access, and will offer eligible families assistance with travel costs, because the treatment will be available only at select hospitals.Kymriah is approved for patients up to age 25 with B cell acute lymphoblastic leukemia who have relapsed at least once with conventional treatment chemotherapy, radiation, and bone marrow transplant.WhileKymriah has not shown the kind of long term toxicities that make conventional therapy such a double edged sword for children, it typically causes severe, temporary side effects within days of infusion, including fevers, low blood pressure, and neurological problems.

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