Today the U.S. Food and Drug Administration approved the chimeric antigen receptor immunotherapy axicabtagene ciloleucel (Yescarta) as a treatment for adults with aggressive non-Hodgkin lymphoma, or NHL, who have failed to respond to standard treatments.
The American Cancer Society estimates that 72,240 people will be diagnosed with NHL this year and 20,140 people will die from it. This type of lymphoma accounts for about 4 percent of all cancers in the United States.
This is the second CAR T-cell therapy approved by the FDA. On Aug. 30 the agency approved the use of another to treat advanced leukemia in children and young adults.
Dr. David Maloney, medical director of cellular immunotherapy at Fred Hutchinson Cancer Research Center and medical director of the Bezos Family Immunotherapy Clinic at Seattle Cancer Care Alliance, Fred Hutch’s clinical care partner, 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 believe 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. In our latest papers, 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.