Auto T-cell Therapy Introduced With $475000 Price Tag

Although China has approved a gene therapy cancer drug and two gene therapy treatments for inherited genetic diseases are on the market in Europe, this is the first to win approval from FDA. That's what a researcher is saying following the FDA's approval of America's first-ever treatment that genetically alters a person's cells to fight cancer.

On Twitter, FDA commissioner Scott Gottlieb called the approval historic. On Wednesday, FDA also expanded the approval of tocilizumab (Actemra-Genentech) to treat auto T-cell-induced severe or life-threatening CRS in patients aged 2 years or older. Its approval comes after an FDA advisory committee backed the drug by a unanimous vote last month. Whereas the time involved in processing is considered critical because of the need for rapid treatment of patients, Novartis has a cryogenic process that enables it to freeze and store samples of patients' blood cells for processing at more convenient times and earlier during the treatment cycle.

Treatment with Kymriah has the potential to cause severe side effects. Nevertheless, researchers caution that, in many respects, it's still early days for auto T cells and other forms of ACT, including questions about whether they will ever be effective against solid tumors like breast and colorectal cancer.

The trial was successful, with 83% of the 63 clinical patients treated for relapsed or refractory B-cell undergoing successful remission within three months of treatment.

"While Novartis' decision to set a price at $475,000 per treatment may be seen by some as restraint, we believe it is excessive", said David Mitchell, founder and president of the advocacy group Patients For Affordable Drugs, and a cancer patient himself.

And although there are more than 600 gene and cell therapies in clinical trials today, according to Bloomberg Technology, future treatments that resemble Kymriah, for different types of cancer and other diseases, are expected to come at similar or even higher costs. For others, Kymriah serves as a "bridge to transplant", keeping them alive longer enough to undergo this therapy.

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"This therapy is a significant step forward in individualised cancer treatment that may have a tremendous impact on patients' lives", said Dr Carl June, the Richard W. Vague Professor of Immunotherapy, director of the Center for Cellular Immunotherapies in Penn's Perelman School of Medicine.

Kymriah will carry a boxed warning because of the treatment's potential to cause deadly side effects, including neurological complications and what's known as cytokine release syndrome, a systemic reaction triggered by the destruction of the cancer cells.

"Patients who get this therapy basically have no chance to survive", Satwani said.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. Instead of getting an updated therapy that works better on a disease every decade or so, we might begin to see second-generation cell therapies in just a few years.

It's not hyperbolic to say that the development of CAR-T immunotherapy has been a revolution in cancer research over the past few years. The patient was a little girl nearly dying and is now five years cancer free.

  • Myrtle Hill