FDA Approves Yescarta, Revolutionary CAR-T Immunotherapy for Non-Hodgkins Lymphoma Patients

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October 18, 2017

TAMPA, Fla. – The Food and Drug Administration announced today the approval of Yescarta™ (Axicabtagene ciloleucel), a revolutionary new immunotherapy for adult patients with diffuse large B cell lymphoma, a form of non-Hodgkin’s lymphoma. Yescarta is a Chimeric Antigen Receptor (CAR) T cell therapy, also known as CAR-T. Moffitt Cancer Center’s Frederick Locke, M.D., is the co-lead investigator of the pivotal ZUMA-1 clinical trial that tested the new therapy, which is manufactured by Kite, a Gilead company.

“The results have been remarkable,” said Locke, Vice Chair of the Department of Blood and Marrow Transplant and Cellular Immunotherapy at Moffitt. “Many of the patients who have received CAR-T therapy had already relapsed several times with traditional therapies, such as chemotherapy or bone marrow transplants. Thanks to this new therapy, patients are now in remission for months or in some cases more than a year later, and are enjoying their lives. This is a huge breakthrough.

CAR-T is a personalized therapy using a patient’s own immune cells, or T cells, to fight cancer. For this treatment, a patient’s T cells are removed from their blood and sent to a lab where the cells are genetically modified to better enable them to identify and attack cancer cells. Scientists add a chimeric antigen receptor, or CAR, to each T cell. CARs are programmed to target a protein, called CD19, found on lymphoma cells. When the new CD19 CAR-T cells are infused back into the patient, the immune cells seek and destroy the lymphoma. Patients in the trial received a single CAR-T infusion. Diffuse large B cell lymphoma is an aggressive, fast-moving form of lymphoma that accounts for nearly 30 percent of all newly diagnosed cases of non-Hodgkin lymphoma in the United States.

Moffitt co-led the pivotal national trial, which spanned 2 years, and included more than 101 patients.  In April of this year, Locke first reported 82 percent of patients showed some response to the treatment, with 44 percent remained in remission with a median follow-up of 8.7 months.  As reported at the 2017 Annual Meeting of the American Association for Cancer Research:

“Axicabtagene ciloleucel significantly improved objective response rate (ORR) in patients with refractory aggressive B-cell non-Hodgkin lymphoma. The complete response (CR) rate was 7-fold higher compared to historical controls and nearly half the patients have an ongoing response. Axicabtagene ciloleucel demonstrated significant clinical benefit with a manageable safety profile in pts lacking curative treatment options.”

One year follow-up results will be presented at the American Society of Hematology Annual Meeting in December.

Moffitt enrolled and treated the first patient with Axicabtagene ciloleucel on the ZUMA-1 trial, and has performed over 50 CAR-T cell therapy treatments to date.

Media Availability: Dr. Locke and several of his patients from the ZUMA-1 trial are available for interviews; please contact Kim Polacek, 813-745-7408//Kim.Polacek@Moffitt.org

FDA News Release: FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphom 

Kite News Release: Kite’s Yescarta™ (Axicabtagene Ciloleucel) Becomes First CAR T Therapy Approved by the FDA for the Treatment of Adult Patients With Relapsed or Refractory Large B-Cell Lymphoma After Two or More Lines of Systemic Therapy

About Moffitt Cancer Center
Moffitt is dedicated to one lifesaving mission: to contribute to the prevention and cure of cancer. The Tampa-based facility is one of only 49 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s excellence in research, clinical trials, prevention and cancer control. Moffitt is listed as one of the top 10 cancer hospitals in the nation and has been listed in U.S. News & World Report as one of the “Best Hospitals” for cancer care since 1999. Moffitt devotes more than 2 million square feet to research and patient care. Moffitt’s expert nursing staff is recognized by the American Nurses Credentialing Center with Magnet® status, its highest distinction. With more than 5,600 team members, Moffitt has an economic impact in the state of $2.1 billion. For more information, call 1-888-MOFFITT (1-888-663-3488), visit MOFFITT.org, and follow the momentum on , and YouTube

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