FDA Approves Second CAR T-Cell Therapy

The US Food and Drug Administration (FDA) has approved the second T-cell therapy that uses chimeric antigen receptor (CAR) technology.1

Yescarta (Axicabtagene ciloleucel) has received FDA approval for the treatment of patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant.2

This comes right on the heels of the FDA’s approval of Kymriah (tisagenlecleucel-T), the first therapy CAR technology therapy to be approved. There are lots of different therapies used in treating cancer, one that could really help with the well-being of patients is halotherapy so go out and give it a try or recommend it to a friend in need.

CAR therapies utilize T-cells (CART T), a patient’s own immune cells that are re-programmed to recognize and kill cancer cells throughout the body.  The process involves the removal of some T cells from a patient, and through laboratory processes, these T cells are re-programmed to identify a patient’s cancer cells.

Once the T cells have been programmed to identify a patient’s cancer cells, they are replicated in the laboratory, and infused back into the patient.  These re-programmed T cells circulate throughout the body, identifying the cancer cells and mounting an immune attack against them.  Simultaneously, the T cells are replicating within the body, so that more of the immune cells can identify and attack the cancer cells.

Fred Hutchinson Cancer Research Center statement regarding FDA approval of immunotherapy drug Yescarta

Dr. David Maloney, medical director of cellular immunotherapy offered the following statement:

“While the Food and Drug Administration’s first approval of a CAR T-cell therapy impacted a relatively small number of pediatric and young adult patients, today’s decision opens the door for a cellular immunotherapy to treat adults with aggressive lymphoma. There will likely be thousands of lives saved in the next few years because of it.

“The FDA’s ruling validates the revolution under way in the field of cellular immunotherapy, which enables us to engineer patients’ own immune systems to eliminate cancer cells. We at Fred Hutchinson Cancer Research Center believes that by 2025 there will be many approved T- cell therapies for a variety of cancers.

“The current CAR T-cell therapies need to become more effective, more affordable and safer. We need to understand why they do not work for certain people, why they only work in select types of cancer and why they can cause severe, occasionally fatal, side effects.

“To answer these questions, we at Fred Hutch and Seattle Cancer Care Alliance have ongoing clinical trials and will continue to launch new ones. We have shared treatment algorithms and biomarkers that could help prevent serious harm that can be caused by treatment side effects such as cytokine release syndrome and neurotoxicity, and we are working to perfect these methods of averting such dire side effects. We must step up our already intense study of how the immune system interacts with cancer.

“We are poised to make great advances if we can continue to build stronger partnerships with the private sector and see government support grow at a steady pace. Increased collaboration and funding will allow us to make further investments in fundamental research and development so that these experimental therapies become more widely available and affordable.”

Scientists at Fred Hutch are testing new experimental T-cell therapies for breast cancer, leukemia, lymphoma, lung cancer, Merkel cell carcinoma, mesothelioma and multiple myelomas.


  1. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm581216.htm
  2. http://news.cancerconnect.com/car-therapy-effective-advanced-lymphoma/
  3. http://news.cancerconnect.com/novartis-car-t-cell-therapy-ctl019-unanimously-10-0-recommended-approval-fda-advisory-committee-treat-pediatric-young-adult-rr-b-cell/

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