The FDA Just Approved The First 'Living' Therapy To Treat Childhood Leukaemia

The FDA has just approved Kymriah, a new form of genetically modified T-cell immunotherapy for treating young patients with a type of blood and bone marrow cancer.

The treatment, called Kymriah, was approved for patients up to 25 years of age who have relapsed or not helped by prior treatment for B-cell acute lymphoblastic leukemia (ALL). Novartis came up with the gene therapy with the University of Pennsylvania.

The treatment involves altering the patient's own immune system by removing T-cells and genetically modifying them to recognize, attack and kill cancer cells.

The FDA approved the first-ever gene therapy in the U.S. on Wednesday. Meanwhile, this week Roche secured FDA approval to use its arthritis drug Actemra (tocilizumab) as a treatment for CAR-T-induced CRS.

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"We're entering a new frontier in medical innovation with the ability to reprogram a patient's own cells to attack a deadly cancer", said FDA commissioner Scott Gottlieb.

There are other severe side effects that can pop up as well that can require hospitalization.

Along with the excitement surrounding CAR-T cells, which are being developed by several companies, there are worries about pricing-the Novartis drug will cost $475,000, although that is reportedly less than expected.

Bruno Strigini, chief executive of oncology at Novartis, said: "We carefully considered the appropriate price and looked at many factors, including the medical and clinical value".

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"Patients who get this therapy basically have no chance to survive", he said. "There are also over 800 cell therapy clinical trials now underway, and a considerable pool of research and pre-clinical work right across the cell therapy sector", said Bruce Levine, PhD, ISCT Commercialization and Immuno & Gene Therapy Committees, Barbara and Edward Netter Professor in Cancer Gene Therapy, University of Pennsylvania Perelman School of Medicine. Most ALL patients respond to initial therapy, but Kymriah will be an invaluable back-up option for relapsed and refractory patients who now have poor prognosis.

"In the next few years", he said, "I think we're going to see dramatic progress and push the boundaries of what many people thought was possible with these adoptive cell transfer-based treatments". The first patients could be treated within days.

Since its founding in 2001, ACGT has allocated approximately $29 million in grants to US and Canadian cancer gene therapy research projects. They'll also have to be less toxic, so more people can consider it instead of only those who have very few other options. "Through our collaboration with Novartis, we are creating the next wave of immunocellular cancer treatments, and are eager to progress CAR-T therapy in a host of haematologic and other cancer types". Penn and Novartis are also investigating the next generation of auto therapies for multiple myeloma, and for solid tumors, through trials in glioblastoma, mesothelioma, and ovarian and pancreatic cancer. In May, Kite disclosed that one person had died in a clinical trial for its late-stage CAR-T therapy from cerebral edema, a condition in which excessive fluid causes the brain to swell. And a year ago, Juno said five people in its clinical trials had died, all from cerebral edema.

In clinical trials, CAR-T therapies have shown remarkable efficacy against blood cancers.

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