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FDA-approved CAR T cell therapies; References External links. Daley, Jim (1 January 2020). "Gene Therapy Arrives". Scientific American; This page was last edited on ...
CARs targeting BCMA were initially reported by Robert Carpenter and James Kochenderfer et al. [35] [36] Anti-BCMA CAR T cells have now been tested in many clinical trials, and anti-BCMA CAR T-cell products have been approved by the U.S. Food and Drug Administration. [37] [38] [39] CAR T cells have also been found to be effective in treating ...
Lisocabtagene maraleucel, a chimeric antigen receptor (CAR) T cell (CAR-T) therapy, is the third gene therapy approved by the US Food and Drug Administration (FDA) for certain types of non-Hodgkin lymphoma, including diffuse large B-cell lymphoma. [6] Lisocabtagene maraleucel was approved for medical use in the United States in February 2021 ...
The first CAR-T therapy, Novartis’ drug Kymriah, received FDA approval in 2017. Since then, another five have been approved. Since then, another five have been approved.
The FDA said in its letters to the companies on Monday that since the approval, it had identified adverse events and clinical trial reports describing T-cell malignancies.
In January, the FDA asked a host of drugmakers including Gilead Sciences, Johnson & Johnson and Novartis to add a boxed warning to their CAR-T cancer therapies, as it received reports of patients ...