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|Posted: Thu Aug 09, 2018 2:10 am Post subject: Once the cells are modified, they are infused back
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WASHINGTON ECCO Mens Intrinsic 2 Slip On 860504-51707 Black , Aug. 30 (Xinhua) -- The U.S. Food and Drug Administration (FDA) on Wednesday approved the country's first gene therapy that reengineers people's own immune cells to treat childhood leukemia.
In a statement, the FDA called the approval "a historic action," saying it will usher in "a new approach to the treatment of cancer and other serious and life-threatening diseases."
"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.
"New technologies such as gene and cell therapies hold out the potential to transform medicine and create an inflection point in our ability to treat and even cure many intractable illnesses."
The U.S. regulator approved Novartis's Kymriah (tisagenlecleucel) ECCO Collin Casual Slip On 535584-51707 Black , formerly known as CTL019, for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.
Kymriah is a novel immunotherapy using an individual patient's own T-cells, a type of white blood cell known as a lymphocyte.
The patient's T-cells are collected and sent to a manufacturing center where they are genetically modified to include a new gene that contains a specific protein, known as a chimeric antigen receptor or CAR Men'S ECCO Collin 535584 Blue , that directs the T-cells to target and kill leukemia cells that have a specific antigen, CD19, on the surface.
Once the cells are modified, they are infused back into the patient to kill the cancer cells.
"Kymriah is a first-of-its-kind treatment approach that fills an important unmet need for children and young adults with this serious disease ECCO Collin Loafer 535904-02001 Black ," said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.
"Not only does Kymriah provide these patients with a new treatment option where very limited options existed, but a treatment option that has shown promising remission and survival rates in clinical trials."
The safety and efficacy of Kymriah were demonstrated in one multicenter clinical trial of 63 pediatric and young adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The overall remission rate within three months of treatment was 83 percent.
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