作为首次对复发/难治性MCL患者进行细胞治疗的[brexucabtagene autoleukel]提供了一个重要的选择,其有效率接近90%,早期临床证据表明在以后的治疗路线中可以持久缓解。” 值得注意的是,FDA批准了brexucabtagene autoleucel风险评估和缓解策略(REMS)。brexucabtagene autoleucel REMS已与Axicabbtagene ciloleucel(Yesc...
推荐的brexucabtagene autoleucel剂量是单次每公斤体重静脉输注1x10 6 个CAR-T细胞(最多1x10 8 个CAR-T细胞)。 参考来源:https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brexucabtagene-autoleucel-relapsed-or-refractory-b-cell-precursor-acute-lymphoblastic....
速递|2021年10月1日FDA批准了靶向CD19的CAR-T细胞疗法Tecartus(Brexucabtagene Autoleucel,KTE-X19)用于B淋巴细胞白血病 2021年10月1日,FDA批准了CAR-CD19 T细胞疗法Tecartus(Brexucabtagene Autoleucel,KTE-X19),用于治疗复发及难治性B淋巴细胞白血病成年患者。 该批准基于Ⅰ/Ⅱ期ZUMA-3试验(NCT02614066)的结果...
(brexucabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The FDA approval was subsequent to the FDA Breakthrough Therapy Designation and a priority review. Additionally, the basis of this approval was supported...
Brexucabtagene Autoleucel(TECARTUS)是一种治疗成人套细胞淋巴瘤(MCL)或急性淋巴细胞白血病(ALL)的药物。该药物在疾病进展后,接受其他治疗期间或之后使用。TECARTUS与其他癌症药物不同,它是由人体自身的白细胞制成的,这些白细胞经过修饰,可以识别和攻击淋巴瘤细胞。
The FDA has approved brexucabtagene autoleucel (Tecartus, Kite Pharma, Inc.) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Efficacy was evaluated in ZUMA-3 (NCT02614066), a single-arm multicenter trial that evaluated brexuc...
The FDA has approved brexucabtagene autoleucel for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The FDA has granted approval to brexucabtagene autoleucel (Tecartus) for the treatment of adult patients with relapsed or refractory B...
The U.S. Food and Drug Administration (FDA) granted accelerated approval to brexucabtagene autoleucel (TECARTUS, Kite, a Gilead Company), a CD19-directed genetically modified autologous T cell immunotherapy, for the treatment of adult patients with relapsed...
A supplement biologics license application has been submitted to the FDA for brexucabtagene autoleucel as a treatment for adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia.
7001#Background:In October 2021, brexucabtagene autoleucel (brexu-cel) became the first CAR-T cell therapy to receive FDA approval for adults (鈮 18 yrs) with relapsed/refractory (r/r) B-ALL. Approval was based on Phase II results of ZUMA-3, a single-arm, open-label, multicenter ...