Novartis' CAR-T therapy or approved in 2017

Novartis' CAR-T therapy or approved in 2017

September 24, 2015 Source: New Kangjie

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On September 23, at the 2015 Shenzhen International BT Leaders Summit, CAR-T therapy inventor Carl Jon told Xin Kangjie that the personalized CAR-T developed by Novartis had been approved by the FDA last year. The cancer therapy CTL019 is estimated to be approved in 2017.

He usually said that it usually takes 8 to 12 years for a drug to go on the market, and CAR-T therapy starts from the first clinical trial in 2010. It is indeed very fast in 7 years.

Five years ago, he took blood from a 6-year-old leukemia girl, Emily Whitehead, and extracted her white blood cells. They modified the white blood cells with modified HIV and taught them to identify and perform tumor cells. Kill, and then reinvent the transformed white blood cells back into the little girl's body.

After continuous high fever (this is the biggest side effect of current CAR-T therapy, Karl said that this is because the white blood cells and cancer cells after the transformation are fighting, fever is a necessary process in the treatment, if there is no fever reaction, there will be no treatment effect ), Emily’s cancer was cured.

"Now, after five years, she still has this modified white blood cell in her body." Carl told reporters that if Emily's cancer recurs, these white blood cells will still kill re-emerging cancer cells, so CAR-T Therapy solves the problem of cancer recurrence. "This is a living medicine, because it will continue to multiply after it enters the body." He said that this is different from any drug previously approved by the FDA.

He pointed out that CAR-T therapy is essentially a technology platform. Although it was originally used for blood cancer and lymphoma, how many kinds of cancers are there in humans, and each type of cancer is finally produced by CAR-T therapy. Different antigens to treat. He said that there are currently 77 clinical trials of antigen-cells for CAR-T therapy, including 48 in the United States, 48 ​​in China, and 20 related clinical trials. In addition, there are 8 in Europe. There is only one in Japan, Australia and Asia Pacific.

However, he also bluntly said that the biggest challenge of CAR-T therapy is how to automate and streamline the complex and costly process that requires professionals, because it is the only way to unify standards and reduce costs.

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