Engineered cell therapy for cancer gets thumbs up from FDA advisers

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By Heidi Ledford

External advisers to the US Food and Drug Administration (FDA) have thrown their support behind a therapy that genetically engineers a patient’s own immune cells to target and destroy cancers.

In a unanimous vote on 12 July, the panel determined that the benefits of CAR-T therapy outweigh its risks. The vote comes as the agency considers whether to issue its first approval of a CAR-T therapy, for a drug called tisagenlecleucel, manufactured by Novartis of Basel, Switzerland.

The FDA is not obligated to follow the recommendations of its advisers, but it often does.

Novartis is seeking approval to use tisagenlecleucel to treat children and young adults who have a form of leukaemia called acute B-cell lymphoblastic leukaemia, and who have not responded sufficiently to previous treatment or have relapsed since that treatment. In the United States, about 15% of children and young adults with acute lymphoblastic leukaemia relapse.

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1 COMMENT

  1. @OP – External advisers to the US Food and Drug Administration (FDA) have thrown their support behind a therapy that genetically engineers a patient’s own immune cells to target and destroy cancers.

    Meanwhile, as science provides new medical solutions, the brain rot of religious indoctrination, is obstructing some people from seeking treatment – or causing them social or family problems if they do!

    http://www.bbc.co.uk/news/health-40802527

    A number of UK women from South Asian backgrounds who have cancer hide it because of a perceived stigma about the disease, the BBC has learned.

    One woman chose to “suffer on [her] own” through chemotherapy for fear of her family’s reaction, and questioned whether God was punishing her.

    Experts said others were seeking help too late, causing preventable deaths.

    In one case a woman sought treatment only when her breast was rotten. She later died as the cancer had spread.

    Pravina Patel, who told the BBC’s Victoria Derbyshire programme about her own experience, stumbled upon a lump in her breast when she was 36.

    She grew up in a strict Indian community where even talking about the disease was considered shameful. When she was diagnosed, she decided to hide it.

    “I just thought if people hear the fact that I’ve got cancer, they’re going to think it’s a death sentence,” she said.

    She remembered worrying that people would say she had lived a “bad life” and God was punishing her for it.

    The stigma surrounding cancer in South Asian communities spans different forms of the disease.

    Ms Patel said there was a reluctance for women to go for a smear test because they did not want to be “defiled” or be considered “no longer pure”.

    She has now completed her chemotherapy and is in remission.

    Ms Patel and her husband got divorced during her treatment – something she says was partly because of cultural expectations about how a wife should be.

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