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CAR T Cell Therapies with Regulatory Approval; CAR T cell (Brand name) Company Approval Agency: Date Target Antigen recognition domain Intracellular signaling domain Indication (Targeted disease / Line of Therapy) Agency Product Number, Drug Label tisagenlecleucel (Kymriah) Novartis: FDA: 08/30/2017 [49] EMA: 08/22/2018 [50] MHLW: 05/15/2019 ...
Since 2017, six CAR-T cell therapies have been approved by the FDA and all are for the treatment of blood cancers, including lymphomas and some forms of leukemia.
Tisagenlecleucel is indicated for the treatment of those under 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse; or adults with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma ...
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 7 ...
Last November, the U.S Food and Drug Administration said it had received reports of patients developing a type of T-cell blood cancer after being treated with CAR-T therapies.Truist Securities ...
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 ...
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