Engineering Immune Cells to Treat Cancer — CAR T Cells

01 September, 2017, 01:35 | Author: Inez Murphy
  • Novartis

The Food and Drug Administration (FDA) has called this a historic moment because it is considered to be the first gene therapy hitting the USA markets.

It is the first gene therapy available in the US, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases, the US Food and Drug Administration (FDA) said.

"We really don't know how long these cells are going to stay active".

The new therapy, which would cost just under €400,000, turns a patient's cells into a "living drug" and trains them to recognise and attack the disease. This is the Kymriah, which has been developed by the laboratories of Novartis in the fight against leukemia lymphoblastic acute in children and young adults, up to 25 years.

The cost of a treatment with the Kymriah is $ 475,000, said Bruno Strigini, the head of the department of oncology at Novartis, during the press conference.

Dr. Otis Brawley, chief medical officer at the American Cancer Society, agreed. "There is still much more work to do", Lichtenfeld told Healthline. It's expected to be a 22-day turnaround for Novartis' Kymriah treatment. In just the last few years, progress with vehicle T cells and other ACT approaches has greatly accelerated, with researchers developing a better understanding of how these therapies work in patients and translating that knowledge into improvements in how they are developed and tested. "It's shown a massive response rate in people with these cancers".

Once this process has been completed, the modified cells are infused back into the patient's body.

While that is the only time the treatment's given, it's not the end of the road.

Those arguments didn't assuage David Mitchell, founder of Patients for Affordable Drugs, and Jamie Love, director nonprofit Knowledge Ecology International, who believe the drug should be more affordable given that taxpayers funded early research. The FDA on Wednesday expanded the approval of Actemra, a rheumatoid arthritis drug that can also treat cytokine release syndrome.

Treatment with Kymriah has the potential to cause severe side effects. But while the treatment is complex, it offers huge rewards. "It's a great accomplishment".

According to a study on CAR-T cells on 63 patients, 83% went in remission after receiving the therapy. Typically, young patients with ALL who fail chemotherapy have only a 30 percent chance of survival.

Cancer cells are seen on a large screen connected to a microscope at the CeBit computer fair in Hanover, Germany, March, 6, 2012. "The disease progresses quickly and is the most common childhood cancer in the USA", the FDA said. Kite's decision date at the FDA in refractory aggressive non-Hodgkin lymphoma is set for November.

The therapy is being licensed and brought to market by the pharmaceutical company Novartis. According to him, a price of $475,000 per treatment was "excessive". STAT notes that only a few hundred patients per year may be eligible for the cell therapy. "This is a potentially curative therapy in patients whose leukemia is unresponsive to other treatments".

Anderson noted that, if Novartis treated 100% of the 600-per-year patient population successfully, that would amount to about $300 million in annual sales-far from blockbuster status, and for a drug that's very expensive to make. Indication-specific pricing is an approach pharmacy benefits manager Express Scripts has been pushing for other cancer drugs.

"There are now upwards of 40 companies developing redirected T cells or NK cells for therapeutic use". And previous year, another company, Juno Therapeutics, said five people in its clinical trials had died, all from cerebral edema. Over a period of up to 12 days, the cells are then reprogrammed in a lab to detect and kill the cancer cells.

"This is big. Big", he said.

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