Intensity的INT230-6获得FDA的快速通道指定,用于治疗复发或转移性三阴性乳腺癌

2019-04-17 不详 MedSci原创

Intensity Therapeutics的INT230-6用于治疗经过两次治疗后失败的复发或转移性三阴性乳腺癌(TNBC),获得美国食品和药物管理局(FDA)的快速通道指定。

Intensity Therapeutics的INT230-6用于治疗经过两次治疗后失败的复发或转移性三阴性乳腺癌(TNBC),获得美国食品和药物管理局(FDA)的快速通道指定。

大约15-20%的乳腺癌检测为雌激素受体、孕激素受体和过量HER2蛋白阴性,即称为三阴性乳腺癌。与其他类型的乳腺癌相比,TNBC被认为更具侵略性并且预后较差,主要是因为靶向药物较少。

INT230-6由两种经过验证的强效抗癌药物和渗透增强剂分子组成,用于瘤内注射,促进药物分散到整个肿瘤并扩散到癌细胞内。在患有各种晚期实体瘤患者的1/2期临床研究(NCT03058289)中正在评估INT230-6。在临床前研究中,INT230-6为完全应答小鼠提供了长期持久的保护作用,INT230-6与检查点抑制剂显示出强大的协同作用,包括抗PD-1和抗CTLA4抗体。

Intensity总裁兼首席执行官Lewis H. Bender表示:"我们非常高兴获得这一快速通道认证,该认证证实了INT230-6作为单一药物治疗复发或转移性三阴性乳腺癌患者的潜力。寻找改善这种疾病的疗法是一项至关重要的未满足医疗需求,我们期待今年与FDA密切合作,开展针对该适应症的2期临床研究。"


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    2019-04-19 xlysu