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posted by martyb on Saturday October 21 2017, @12:09AM   Printer-friendly
from the a-third-chance-at-life dept.

The U.S. Food and Drug Administration (FDA) has approved a gene therapy for non-Hodgkin's lymphoma (blood cancer):

The Food and Drug Administration on Wednesday approved the second in a radically new class of treatments that genetically reboot a patient's own immune cells to kill cancer.

The new therapy, Yescarta, made by Kite Pharma, was approved for adults with aggressive forms of a blood cancer, non-Hodgkin's lymphoma, who have undergone two regimens of chemotherapy that failed.

The treatment, considered a form of gene therapy, transforms the patient's cells into what researchers call a "living drug" that attacks cancer cells. It is part of the rapidly growing field of immunotherapy, which uses drugs or genetic tinkering to turbocharge the immune system to fight disease. In some cases the treatments have led to long remissions.

"The results are pretty remarkable," said Dr. Frederick L. Locke, a specialist in blood cancers at the Moffitt Cancer Center in Tampa, and a leader of a study of the new treatment. "We're excited. We think there are many patients who may need this therapy."

He added, "These patients don't have other options."

About 3,500 people a year in the United States may be candidates for Yescarta. It is meant to be given once, infused into a vein, and must be manufactured individually for each patient. The cost will be $373,000.

Also at The Associated Press, CNN, and STAT News.

Previously: FDA Approves a Gene Therapy for the First Time
FDA Committee Endorses Gene Therapy for a Form of Childhood Blindness


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  • (Score: 2) by deimtee on Saturday October 21 2017, @08:18PM (2 children)

    by deimtee (3272) on Saturday October 21 2017, @08:18PM (#585766) Journal

    So what are the down side risks of this drug that warrant subjecting patients to the torture of chemo, TWICE, with the disease progressing all the time?

    NHL has a weird survival curve to chemo treatment until you work out that there are actually two diseases called NHL.
    Approx 50% of patients get one type, and CHOP-R chemo cures it.
    The rest get the other type, and chemo does nothing at all except make the patient sicker.
    There is no diagnostic test to tell the two types apart except administering chemo and seeing if it cures you.

    --
    If you cough while drinking cheap red wine it really cleans out your sinuses.
    Starting Score:    1  point
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  • (Score: 0) by Anonymous Coward on Sunday October 22 2017, @12:24AM (1 child)

    by Anonymous Coward on Sunday October 22 2017, @12:24AM (#585830)

    Is it as simple as two types? I read up on this (a friend died from it) several years ago and my memory is that there were many varieties.

    • (Score: 2) by deimtee on Sunday October 22 2017, @02:26AM

      by deimtee (3272) on Sunday October 22 2017, @02:26AM (#585847) Journal

      Two types is probably an oversimplification, two groups would be closer, but the the effect is almost the same. Chemo either cures or does nothing, it doesn't seem to have a range of delaying responses like chemo does with most cancers.
      I too did a lot of reading on it a few years back when a close relative got it. One of the papers pointed out that if you separated patients into two groups, they both had standard survival patterns, it was just that one was extremely lethal, and the other easily treated. The 50% survival figure is an artifact of the fact that they can't tell them apart pre-treatment. It's actually a mix of 0% and 100%

      I think that is why they are insisting on two rounds of chemo before this new treatment. It will cut their patient load in half by removing everyone chemo can help.
      Also, if there is an underlying difference then tuning the treatment for the version that chemo doesn't cure would actually inprove the overall survival, and be the ethical thing to do.

      --
      If you cough while drinking cheap red wine it really cleans out your sinuses.