https://www.cancernetwork.com/view/liso-cel-receives-fda-approval-for-the-treatment-of-r-r-large-b-cell-lymphoma https://www.onclive.com/view/fda-approves-liso-cel-for-refractory-large-b-cell-lymphomaAbramson JS, Palomba ML, Gordon LI, et al. Pivotal safety and efficacy results from Trans...
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Another potential side effect of CAR T-cell therapy—an off-target effect—is a mass die off of B cells, known as B-cell aplasia. CD19 is also expressed on normal B cells, which are responsible for producing antibodies that kill pathogen...
Global Regulatory Approvals Since 2017, 13 CAR-T cell therapies have reached commercialization across multiple healthcare markets. Seven therapies have been approved by the U.S. FDA, after which approvals for them were issued in other major healthcare markets as well. These therapies include: ...
Table 1 Current FDA approvals of CAR T therapies Full size table Fig. 1 Timeline of CAR T therapy FDA approvals Full size image Main text CAR structure Optimal activation of naive T cells requires two signals, a primary signal via engagement of T cell receptor (TCR) with an antigen presen...
With FDA approval for advanced lymphoma, second CAR T-cell therapy moves to the clinic. National Cancer Institute go.nature.com/2FDRTC5 (25 October 2017). Brudno, J. N. et al. Allogeneic T cells that express an anti-CD19 chimeric antigen receptor induce remissions of B-cell malignancies ...
and potentially reduce the time for approval for treatments for other critical or fatal diseases with no alternative therapeutic option,” Catherine Bollard, ISCT President and an invited expert to the FDA advisory panel that recommended Kymriah’s approval. “The FDA approval by Novartis i...
(Equecabtagene Autoleucel,Eque-cel) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of Non-renal Systemic Lupus Erythematosus (SLE) and Lupus Nephritis(LN).This is the fifth IND approval obtained forEque-cel for autoimmune diseases in China and the ...
and have achieved very good clinical efficacy. We have published several research papers in leading scientific journals. The US IND approval of Eque-cel for the treatment of gMG, a several autoimmune disease, represents a recognition of the FDA of the potential clinical value of our research dire...