FDA approves ACGT-funded cancer treatment

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01 September, 2017

"This is the first-ever true gene therapy treatment made available to the USA population and will help accelerate the speed at which we will see even more gene-based therapies come to fruition".

It is the first gene therapy to be approved by the FDA. 5 years ago, for the first time, he used the CAR-T cell therapy to treat a girl child who was close to death but now she is completely ok.

Novartis said the treatment has an 83 percent success rate for a form of leukemia that has proven very hard to treat by other methods.

The FDA-approved CAR-T therapy administers a customized treatment that uses a patient's own T cells, which plays an important role for a person's immunity system.

US regulators approved a revolutionary new cancer treatment from Novartis AG on Wednesday, the first in a group of coming therapies that offer breakthrough cures for dire cases as well as stratospheric costs. Novartis said it hopes to have an initial network of 20 treatment centers within a month with plans to expand that to 32 by the end of the year.

"It's a new method of treating cancer that I think we will successfully further exploit over the next decade". The treatment is also known as CAR-T.

The price per person is likely to be much higher when accounting for additional costs, such as drugs to prepare the patient for the treatment and medicines to control potential side-effects.

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Cooper said fewer inpatient and outpatient visits for treatment and fewer hospitalizations are likely to result from treatment with auto T-cell therapy, which he said would allow parents and other family members and caregivers "to resume a normal life, including the possibility to return to work".

Success with those patients is key to Novartis turning Kymriah into the $1 billion-a-year blockbuster drug the Swiss company predicts it will eventually become, but analysts say it is anyone's guess when it will start covering its costs.

The treatment involves altering the patient's own immune system by removing T-cells and genetically modifying them to recognize, attack and kill cancer cells. It carries a boxed warning for cytokine release syndrome (CRS), which is a systemic response to the activation and proliferation of vehicle T-cells causing high fever and flu-like symptoms, and for neurological events. Many previous trials have offered stunning results, with sustained remissions in anywhere from 60 to 90 percent of patients.

His current research is focused on similar reprogramming of cells but for the detection of lung cancer cells.

FDA Commissioner Dr. Scott Gottlieb released a statement on Kymriah's potential for patients, saying it will revolutionize cancer treatment.

Kymriah is expected to be available through a network of certified treatment centers throughout the United States.

Questions also remain about the drug's possible long-term side effects and ability to prevent ALL from coming back. "Novartis should not get credit for bringing a $475,000 drug to market and claiming they could have charged people a lot more".


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