NKMAX said on Thursday that it has received FDA approval for its natural killer (NK) cell therapy SNK01 to treat Parkinson's disease under the Expanded Access Program (EAP). NKMAX has received sympathetic approval from the FDA for its NK cell therapy, SNK01, to treat Parkinson's disease ...
the First Approved Engineered Cell Therapy for a Solid Tumor. Retrieved August 1, 2024, from https://www.adaptimmune.com/investors-and-media/news-center/press-releases/detail/271/adaptimmune-receives-u-s-fda-accelerated-approval-of
2024年2月16日,美国食品药品监督管理局(FDA)传来喜讯,宣布加速批准Iovance Biotherapeutics公司的肿瘤浸润淋巴细胞(TIL)疗法lifileucel上市。作为全球首款批准上市的TIL疗法,lifileucel将用于治疗不可切除或转移性黑色素瘤成人患者,展现出里程碑式的意义,为实体瘤治疗领域开启崭新的篇章。 TIL疗法 TIL 是存在于肿瘤微环...
PDUFA日期:2024.02.24 Lifileucel是由Iovance Biotherapeutics研发的一种TIL(Tumor Infiltrating Lymphocyte Cell,肿瘤浸润淋巴细胞)疗法,正在临床上开展多项单药或者组合疗法,用于治疗在既往抗 PD-1/L1 治疗和靶向治疗(如适用)期间或之后进展的晚期黑色素瘤患者(图1)。 图...
Lifileucel是由Iovance Biotherapeutics研发的一种TIL(Tumor Infiltrating Lymphocyte Cell,肿瘤浸润淋巴细胞)疗法,正在临床上开展多项单药或者组合疗法,用于治疗在既往抗 PD-1/L1 治疗和靶向治疗(如适用)期间或之后进展的晚期黑色素瘤患者(图1)。 图1. Lifileucel的开发进展 ...
老一代的NK3受体拮抗剂，例如osanetant和talnetant，但只有fezolinetant针对HPC轴，这可能是得益于fezolinetant有利的药代动力学特征，可以穿过血脑屏障。Fezolinetant于2023年5月获得FDA批准，商品名为VEOZAH。Fezolinetant分子中含有一个4-氟苯甲酰的含氟结构。05 Miebo 图5. Perfluorohexyloctane化学结构 Perflu...
[5]https://www.amgen.com/newsroom/press-releases/2024/05/fda-approves-imdelltra-tarlatamabdlle-the-first-and-only-tcell-engager-therapy-for-the-treatment-of-extensivestage-small-cell-lung-cancer [6]https://www.fda.g...
突破性治疗认定(Breakthrough Therapy Designation,BTD)是美国食品药品监督管理局(FDA)自2012年7月开始实施的一种新药研发与审评的加速通道,旨在加快用于治疗严重疾病的药物(包括生物制品)的研发与审评,从而尽早满足患者的治疗需求。获得BTD的药物必须同时满足下列条件:(1)用于治疗严重疾病;(2)与现有治疗药物相比,有初...
The FDA has granted a fast track designation to IDP-023, a natural killer (NK) cell therapy, for the treatment of patients with non-Hodgkin lymphoma and multiple myeloma. Fast track designation is given to drugs that treat serious conditions or fill unmet needs. ...
multicentre study examining the pharmacokinetics, efficacy, immunogenicity, and safety of atezolizumab subcutaneous versus intravenous administration in previously treated locally advanced or linkstatic non-small-cell lung cancer and pharmacokinetics comparison with other approved indications[J]. Annals of Oncolog...