Cancer therapy approved by FDA uses body’s own cells as a ‘living drug’::undefined

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    410 months ago

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    After undergoing surgery, radiation and three different therapies, Scott Goedeke faced a tough reality: The cancer that first surfaced on the roof of his mouth had spread to a lymph node in his neck.

    On Friday, the U.S. Food and Drug Administration approved its use to treat adults with a skin cancer like Goedeke’s — melanoma that has spread or can’t be removed with surgery, after other approaches have failed.

    Shares of Iovance Biotherapeutics, the California-based company that makes the therapy, surged more than 30 percent on Tuesday, the first full day of trading following the FDA’s approval.

    “The concept that the FDA has now acknowledged is that you can use a patient’s own cells as a living drug to treat their disease, and that to me is a very exciting step forward,” said Steve Rosenberg, a senior investigator for the National Cancer Institute who has helped pioneer the newly approved therapy since the 1980s.

    The new individualized therapy, called tumor-infiltrating lymphocytes, enlists the relatively small number of the body’s T cells that see a tumor as a threat and produces a lab-grown army of them.

    The FDA action is also a signal to the pharmaceutical industry that there is a commercial path to success, said Jason Bock, chief executive of CTMC, a company spun out of MD Anderson Cancer Center that contracts with biotech firms to help manufacture cell therapies.


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