[7] Adaptimmune Receives U.S. FDA Accelerated Approval of TECELRA® (afamitresgene autoleucel), the First Approved Engineered Cell Therapy for a Solid Tumor. Retrieved August 1, 2024, from https://www.adaptimmune.com/investors-and-media...
美国FDA今日发布两项最终版指南文件,旨在协助业界开发使用基因组编辑的基因疗法和体外制造的CAR-T细胞产品。 长达19页的基因组编辑指南文件明确了FDA对使用加速批准通道支持基因组编辑疗法开发的立场。包括FDA旗下生物制品评价和研究中心(CBER)主任Peter Marks博士在内的FDA官员已多次表示,加速批准是加快基因疗法上市的有...
“今年下半年,我们计划继续在CAR-T复发患者群体中为受试者提供经优化的PBCAR0191,同时进一步降低清淋药物剂量至标准水平,提高患者的整体治疗指数。我们还希望与FDA举行会议,审查我们的数据并指导下一步工作,希望可以在年底前更新PBCAR0191数据。”List博士补充道。 参考资料: [1]https://precisionbiosciences.com/ [...
2021年2月5日,美国FDA批准了百时美施贵宝(BMS)的Breyanzi。该药为市场上第三种CAR-T的基因疗法。该疗法可用于治疗特定类型大B细胞淋巴瘤的成年患者,这些患者在至少两轮全身性治疗后无反应或治疗后复发。 Breyanzi是治疗包括弥漫性大B细胞淋巴瘤在内的特定类型的非霍奇金淋巴瘤疗法。在审评期间,FDA曾授予Breyanzi孤...
2021年2月5日,美国FDA批准了百时美施贵宝(BMS)的Breyanzi。该药为市场上第三种CAR-T的基因疗法。该疗法可用于治疗特定类型大B细胞淋巴瘤的成年患者,这些患者在至少两轮全身性治疗后无反应或治疗后复发。 Breyanzi是治疗包括弥漫性大B细胞淋巴瘤在内的特定类型的非霍奇金淋巴瘤疗法。在审评期间,FDA曾授予Breyanzi孤...
Autolus’ CAR T Aucatzyl wins US FDA nod for leukemia Autolus Therapuetics plc has been granted FDA approval for Aucatzyl (obecabtagene autoleucel) for the treatment of acute lymphoblastic leukemia in adults, becoming the first marketed CAR T therapy that does not have a risk evaluation and...
1.Immunofoco Announces the Dual Approval of IND Applications by the U.S. FDA and China CDE for the First EpCAM CAR-T Targeted at Advanced Solid Tumors | BioSpace 2.Safety, tolerability, and preliminary efficacy results in patients with advanced gastric/gastroesophageal junction adenocarcinoma from...
In February 2022, CT103A was granted the “orphan drug designation (ODD)” by the FDA for the treatment of multiple myeloma. In June 2022, CT103A was accepted by the NMPA for the NDA application for the treatment of relapsed/refractory multiple myeloma and included in the priority review....
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...