Aucatzyl是一款靶向CD19的新型CAR-T细胞疗法,具有新型CD19结合域CAT,可实现快速抗原解离率,可提高CD19 CAR-T疗法的持久性,同时降低降低T细胞耗竭风险及潜在毒性。 Aucatzyl本次获美国FDA批准,主要是基于一项Ib/II期FELIX临床研究的...
[4] Bristol Myers Squibb’s Abecma (idecabtagene vicleucel) Becomes First CAR T Cell Therapy Approved in the European Union in Earlier Lines for Triple-Class Exposed Relapsed and Refractory Multiple Myeloma. Retrieved March 22, 2024, from https://www.businesswire.com/news/home/20240320035615/en...
批准靶向B细胞成熟抗原(BCMA)的CAR-T细胞疗法Abecma(idecabtagene vicleucel)用于治疗复发或难治性多发性骨髓瘤成年患者,这些患者在接受包括免疫调节剂(IMiD)、蛋白酶体抑制剂(PI)和抗CD38单克隆抗体的两种或更多先前治疗后疾病出现进展。
当地时间4月1日,美国Kite(吉利德科学旗下公司)宣布,美国食品药品管理局(FDA)批准Kite 公司的CAR-T细胞治疗药品Yescarta®用于一线化疗免疫疗法难治或一线化疗免疫疗法后12个月内复发的大B细胞淋巴瘤(LBCL)成年患者。 全球首款获得FDA批准作为LBCL二线疗法的CAR-T药物 此次批准是基于ZUMA-7 的临床研究结果,Yescart...
FDA approval brings first gene therapy to the United States CAR T-cell therapy approved to treat certain children and young adults with B-cell acute lymphoblastic leukemia SHARE TWEET LINKEDIN PIN IT EMAIL PRINT For Immediate Release August 30, 2017 ...
Kymriah, a cell-based gene therapy, is approved in the United States for the treatment of patients up to 25 years of age with B-cell precursor ALL that is refractory or in second or later relapse. Kymriah is a genetically-modified autologous ...
1月19日，FDA正式要求目前美国已上市的6种CAR-T细胞治疗产品，全部要在说明书上添加新的“黑框警告”...
FDA Advisory Committee Recommends Approval of CAR-T Therapy for Pediatric ALLNalleyCatlin
The FDA gave the green light to Novartis's tisagenlecleucel for the treatment of acute lymphoblastic leukaemia (ALL), marking a historic approval for a first-in-modality chimeric antigen receptor (CAR) T cell therapy. CAR Ts are an ex vivo form of gene therapy, in which T cells are rem...
UPDATED AUGUST 31 // The first T-cell therapy that uses chimeric antigen receptor (CAR) technology has been approved today by the US Food and Drug Administration (FDA), paving the way for the other products using this novel approach that are in development. "We're entering a new frontier ...