Saturday, 25 November, 2017

FDA Approves Yescarta, First CAR T-Cell Therapy for Lymphoma

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Jeannie Matthews | 21 October, 2017, 00:45

"It takes our most powerful immune cells in the body known as T-cells and it reengineers them to fight the B-cells that are causing the cancer in the first place", he said, adding that the innovation also has implications for more cancers. There are approximately 72,000 new cases of National Hockey League diagnosed in the United States annually. Called immunotherapy, the patient's infection-fighting T-cells are extracted and genetically engineered with a new gene to pinpoint and kill the lymphoma cells.

The FDA said diffuse large B-cell lymphoma is the most common type of non-Hodgkin's Lymphona in adults and there are approximately 72,000 new cases of National Hockey League diagnosed in the United States each year.

This approval marks the second gene therapy to be approved by FDA and the first to be approved for certain types of non-Hodgkin lymphoma.

Diffuse large B-cell lymphoma is the most common type of the disease in adults, with some 72,000 new patients diagnosed annually in the USA, according to the American Cancer Society, and some 20,000 will die from it this year.

Axi-cel was approved with a boxed warning regarding cytokine release syndrome (CRS), which occurred in 13% of patients in the ZUMA-1 trial.

Gilead, which recently acquired Kite Pharma, said the list price for Yescarta, which is to be administered just once to each patient, would be $373,000. Patients must be informed of these risks before receiving the therapy. "We remain committed to supporting the efficient development of safe and effective treatments that leverage these new scientific platforms".

Nubia Z17S, Z17 miniS with 4 cameras launched: Price, specifications, features
Even though that sound a bit ridiculous, but I guess everyone is entitled to their own perspectives, even if they are irrational. The flagship Nubia Z17S comes with 6GB RAM and 64GB storage and is priced at RMB 2,999, which is around Rs 29,594 on conversion.

"The approval of Yescarta brings this innovative class of CAR-T cell therapies to an additional group of cancer patients with few other options - those adults with certain types of lymphoma that have not responded to previous treatments", said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. Commissioner Scott Gottlieb announced alongside the approval that FDA will soon issue a comprehensive agency policy clarifying how FDA's expedited programs apply to gene therapy products. The FDA has linked a risk evaluation and mitigation strategy with the approval: hospitals and their associated clinics that dispense axicabtagene ciloleucel need to be specially certified. Also, patients must be informed of the potential serious side effects and of the importance of promptly returning to the treatment site if side effects develop. Arie Belldegrun, MD, FACS, Founder of Kite, said in a statement.

The treatment is based on CAR-T therapy, which was developed by Israeli researchers at the Weizmann Institute of Science and the Tel Aviv Sourasky Medical Center.

Similar CAR-T therapies are being developed by Juno Therapeutics Inc., Bluebird Bio Inc., and others.

People with advanced lymphoma now have another type of treatment to consider.

Axicabtagene ciloleucel (Yescarta) has been approved to treat adult patients with diffuse large B-cell lymphoma who have not responded to or who have relapsed after at least 2 other kinds of treatment. While this therapy may be groundbreaking, it comes with potentially lethal side effects.

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