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全球首款!TIL疗法向FDA完成滚动提交,距离上市再进一步!

细胞基因治疗前沿
1641
1年前

TIL疗法

FDA





3月24日,TIL细胞疗法领军企业Iovance Biotherapeutics宣布,已向FDA完成Lifileucel的生物制品许可申请(BLA)的滚动提交,意味着全球首款TIL细胞疗法距离上市再进一步。Lifileucel是一款TIL细胞疗法,针对晚期(不可切除或转移性)黑色素瘤,此前,Lifileucel的开发进展并不顺利,其上市申请屡次与FDA未能达成一致。

Frederick Vogt博士

Iovance临时总裁兼首席执行官Frederick Vogt博士表示,完成Lifileucel的BLA提交是我们为实体肿瘤提供首个个体化、一次性细胞疗法的关键一步。我要感谢参与C-144-01临床试验的患者和医生以及FDA审查团队的承诺和支持,以及我们的内部团队为完成Iovance的第一次BLA提交所付出的巨大努力。我们的商业化准备工作仍在进行中,以支持今年晚些时候发布。

TIL细胞疗法,是一种新型的细胞免疫疗法,可以说是免疫疗法赛道上一个异军突起的抗癌新疗法,也是个体化医疗技术和现代医学技术充分融合的一个典范。由TIL细胞疗法引申研发出来的抗体将会被制成广谱药物,将来癌症患者不仅可以依靠激发自身的免疫力,还可以依靠这些合成抗体,一起与癌细胞作斗争,可为癌症患者带来更多的治疗选择。

Lifileucel临床试验结果
截图来源:药融云临床试验结果数据库

Lifileucel为Iovance的首发管线,有多项单药治疗和联合治疗的临床研究在进行中,且试验结果均显示积极。Lifileucel是一种自体的,即可注入的TIL细胞疗法,在转移性黑色素瘤的治疗中具有独特的疗效。据药融云全球药物研发数据库显示,目前Lifileuce已获得了美国FDA认证的快速通道、孤儿药、再生医学先进疗法以及突破性疗法的特殊审批。

Lifileucel特殊审批认证
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截图来源:药融云全球药物研发数据库

Iovance Biotherapeutics是一家新兴的生物技术公司,于2007年9月17日在内华达州成立,专注于基于肿瘤浸润淋巴细胞(TIL)的新型癌症免疫疗法的开发和商业化,并于2015年02月26日在美国NASDAQ证券交易所上市,目前是TIL细胞疗法领域领头羊。

Iovance Biotherapeutics公司研发管线
来源:Iovance Biotherapeutics公司官网


参考资料:
[1] 药融云数据库
[2] Iovance Biotherapeutics公司官网


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*声明:本文由入驻药融云的相关人员撰写或转载,观点仅代表作者本人,不代表药融云的立场。
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