Last week the U.S. Food and Drug Administration (FDA) approved the first gene therapy in the U.S. The therapy will be used to treat children with acute lymphoblastic leukemia (ALL), the most common blood cancer in children. According to CNN, the treatment will give some patients a second chance after the first drugs have failed. The FDA reported that this applies to up to a fifth of patients.

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The new therapy is called chimeric antigen receptor T cell (CAR-T) therapy, the treatment referred to as Kymriah, and will be using the immune system to fight the cancer. The way cancer occurs is a mutation that causes unchecked cell division, therefore resulting in continued growth of damaged cells. The immune system does not always realize that there is something wrong with these cells. A group of drugs that had already been approved by the FDA, checkpoint inhibitors, allow the immune system to attack tumor cells that are usually left intact.

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Although the new therapy uses the immune system, it works differently from the checkpoint inhibitor drugs. Each dose of Kymriah uses the patient’s immune cells that have been sent to a lab to be genetically modified by a virus, according to CNN. The cells are able to find and destroy the cancer source.

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“We’ve never seen anything like this before and I believe this therapy may become the new standard of care for this patient population,” Dr. Stephan Grupp, director of cancer immunotherapy at Children’s Hospital of Philadelphia, told CNN.

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In order to perform the treatment, hospitals and clinics must become certified. Initially there are plans certify 20 treatment centers within a month and 32 by the end of the year. The treatment is not cheap, but patients who do not respond within a month will not be charged the $475,000 by Novartis, the drug company that makes Kymriah, reported CNN.

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This decision by the FDA is a landmark in the gene therapy field and also shows a change in the way cancer can be treated. Rather than bringing in other substances to weaken the cancer, the goal of the CAR-T cell therapy is to improve the immune system to fight the cancer.

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“It’s a paradigm shift,” said Dr. Kevin Curran, from the pediatric bone marrow transplantation service at Memorial Sloan Kettering Cancer Center, to Time. “These are actually living cells that we pull out of  the system, modify in the lab, teach how to find cancer, turn back  on and put back into patients. To do that definitely shifts everything.”

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The first patient ever treated with the CAR-T therapy is in remission seven years after treatment, according to Time. This patient is living proof that the therapy can work to eliminate cancer. There are hopes that this technology will be able to be used to cure other types of cancer.

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With approving this sort of technology, there is also an ethical dilemma. Although working to cure cancer is not an issue, gene therapy is thought to be able to be used for a variety of things. For one thing, the difference between appropriate and inappropriate uses for gene therapy is a gray area. This may include which disabilities and disorders should be fixed or what is not debilitating enough. Gene therapy may also raise concerns related to religious beliefs in certain people.

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There have also been discussions about whether gene therapy could be used to enhance basic human traits, for example intelligence and athletic ability. Additionally, the current gene therapy cannot be passed to the patients’ children. This would require germline gene therapy, which may fix one problem, but could cause unexpected side effects during prenatal development.

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The advisory panel that approved this new gene therapy unanimously decided that the benefit outweighed the risks in this circumstance. Novartis must manage a followup to look at the safety of the treatment longterm.