''So yescarta isn’t the first treatment that the patients go for? Hmmmm.''
GILD is running the ZUMA-7 (PhIII) trial and it (Yescarta) is being tested in 2nd line DLBCL and ZUMA-12 (PhII) in 1st line DLBCL. At least seven other CAR-T trials are ongoing with more planned. Also, around a dozen TCR-T trials in different solid cancers as well (most under CRADA).
Abstract Axicabtagene ciloleucel (YESCARTA®, Kite Pharma, a Gilead Company) and tisagenlecleucel (KYMRIAH®, Novartis Pharmaceuticals Corp.) are two CD19-directed chimeric antigen receptor T cell (CD19 CAR T) products that are currently approved by the U.S. Food and Drug Administration, the European Medicines Agency, Health Canada, Ministry of Health, Labor and Welfare (Japan) and Therapeutic Goods Administration (Australia) for treatment of specific subtypes of relapsed/ refractory aggressive B cell non-Hodgkin lymphoma (NHL).
While this approval has been transformative in the use of cellular immunotherapy in lymphoma, there are
concerns
regarding appropriate utilization of this novel therapy, as well as short- and long-term
toxicities.
To address these issues, representatives of American Society of Transplantation and Cellular Therapy (ASTCT) convened to recognize and address key issues surrounding the clinical application of CD19 CAR T cell therapy in B cell lymphomas, in collaboration with worldwide experts and members of International Society of Cell and Gene Therapy (ISCT), American Society of Hematology (ASH), Foundation for the Accreditation of Cellular Therapy (FACT) and European Society for Blood and Marrow Transplantation (EBMT).
The aim of this article is to provide consensus opinion from experts in the fields of hematopoietic cell transplantation, cellular immunotherapy, and lymphoma regarding key clinical questions pertinent to the utilization of CD19 CAR T for the treatment of NHL.
As the clinical practice using CAR T cells grows worldwide, we anticipate that this guidance will be relevant for hematology/oncology physicians who care for patients with lymphomas.
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