First CAR T Cell Therapy for Adults Approved by FDA

ASGCT Staff - October 20, 2017

Oct. 19, 2017—With Wednesday’s FDA approval of axicabtagene ciloleucel (Yescarta®, Kite Pharma, Inc/Gilead), the administration has put into clinicians’ hands the first CAR T cell therapy for adult patients. The FDA approval, the first for adults with relapsed or refractory large B-cell lymphoma and second-ever approved CAR T cell therapy, arrives with the continued unwavering advocacy and support from the American Society of Gene & Cell Therapy. The Society also extends an excited and hopeful congratulations to all who worked to bring this breakthrough therapy to patients across the country.

Yescarta represents a realistic chance for the thousands of patients who would previously have been out of options in their fight against large B-cell lymphoma. Additionally, the accelerating pace at which gene and cell therapies are being either approved or recommended for approval demonstrates the fever pitch excitement with which our member researchers are improving the safety and efficacy of these innovative, paradigm-shifting treatments.

“ASGCT is thrilled that the first CAR T cell therapy for adults with lymphoma has been approved in the United States,” Dr. Helen E. Heslop, ASGCT President and Director of the Center for Cell and Gene Therapy at Baylor College of Medicine, Texas Children’s Hospital and Houston Methodist Hospital says. “The continued acceleration and approval of gene and cell therapies has the potential to transform the way that we treat not only lymphomas but many other diseases.”

The FDA’s full release on the approval of Yescarta, including a statement from FDA Commissioner Scott Gottlieb on the importance of CAR T cell therapy advancement, is available online: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm581216.htm

The American Society of Gene & Cell Therapy is the primary professional membership organization for gene and cell therapy. The Society's members are scientists, physicians, patient advocates, and other professionals. ASGCT's mission is to advance knowledge, awareness, and education leading to the discovery and clinical application of gene and cell therapies to alleviate human disease. For more information, please visit www.asgct.org

For media members interested in speaking with experts in gene therapy or CAR T-cell therapies, please contact ASGCT’s Alex Wendland by phone (414-278-1341) or by email (awendland@asgct.org).

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