Kymriah is a customized treatment, meaning each dose contains the patient's own T-cells (white blood cells known as lymphocyte).

Shares of Gilead Sciences Inc, which this week announced an $11.9 billion deal to buy Kite Pharma, were up 6.2 percent to $80.47 on Wednesday afternoon, as Kite is widely expected to receive the next USA approval of a CAR-T therapy for a different blood cancer.

"Before CAR-T cells, we've been able to save about 70 per cent of children with leukaemia, but those other 30 per cent of children who don't respond to chemo have died".

The new gene therapy has shown remarkable results in a clinical trial of 63 children and young adults battling severe lymphoblastic leukemia.

The new leukemia drug reprograms a patient's own cells to attack the deadly cancer, possibly in a single treatment.

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This is the first type of gene therapy to hit the US market called the CAR-T cell treatment that was developed by Novartis Pharmaceuticals and the University of Pennsylvania.

The Food and Drug Administration (FDA) has called this a historic moment because it is considered to be the first gene therapy hitting the US markets. Priced at $475,000, it will be offered at just 32 sites around the country. The genetic changes wrought through the customized process creates coding for a protein known as a chimeric antigen receptor, or auto. "The lessons learned from the clinical trials of vehicle T-cell operations will assist us in being able to provide to the larger population".

On the flip side, that sticker doesn't include the hospital expenses required when Novartis collects each patient's T-cells for re-engineering, and later, when the personalized Kymriah is administered.

There are drawbacks to the therapy such as life-threatening side effects, including risky drops in blood pressure and the FDA has said hospitals and doctors should be trained and certified to administer it, and that they stock a certain drug needed to quell severe reactions.

Professor Trapani said that at this stage CAR-T would not be used as an initial treatment but as an option for those who don't respond to existing forms of cancer treatment such as chemotherapy and radiotherapy. The manipulated cells could cause a cytokine storm, which could present with high fever, low blood pressure, long congestion and other life-threatening issues.

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"We believe it is excessive", said David Mitchell, a cancer patient who founded the group. It also will cost $475,000, but the gamble may be worth it.

The FDA has taken necessary steps to check the side effects that are generated due to the CAR-T treatment. They'll also have to be less toxic, so more people can consider it instead of only those who have very few other options.

"Before that, it may be that Australian patients travel overseas to access the therapy".

Those early-stage clinical trials, in which more than 90 percent of patients achieved a complete remission one month after receiving the therapy, led to a global registration trial in 2015, involving 68 children and young adults with advanced ALL treated at 25 centers across the world.

The Novartis-Penn Center for Advanced Cellular Therapeutics (CACT) opened in 2016 and hosted Vice President Joe Biden at the launch of his Cancer Moonshot initiative, cementing Penn's role as an global innovator in the development and manufacturing of personalized cellular therapies.

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