First CAR T-Cell Therapy Approved in U.S.

The genetically modified blood cells will be used for patients with a type of acute lymphoblastic leukemia, when other treatments fail.

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Each patient’s T-cells will be harvested from the body and genetically programmed to target leukemia cells. ALLINONEMOVIE, PIXABAYThe US Food and Drug Administration (FDA) announced today (August 30) that it has approved the first therapy involving chimeric antigen receptor (CAR) T cells for clinical use. Each dose of Novartis’s drug, Kymriah, will consist of a patient’s own white blood cells, harvested from the body and genetically programmed to seek an antigen on the surface of leukemia cells.

“We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer,” says FDA Commissioner Scott Gottlieb in a statement. “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.”

Kymriah is approved for patients 25 years old and younger who have B-cell acute lymphoblastic leukemia, and whose disease has relapsed at least twice or is still detectable after other treatment. In a clinical trial, the therapy left 83 percent of such patients cancer-free after three months. STAT notes that only a few hundred patients per year may be eligible for the cell therapy. ...

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Meet the Author

  • Shawna Williams

    Shawna was an editor at The Scientist from 2017 through 2022. She holds a bachelor's degree in biochemistry from Colorado College and a graduate certificate and science communication from the University of California, Santa Cruz.
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