和黄医药启动治疗转移性结直肠癌新药国际三期期临床试验FRESCO-2
和黄医药(HCM.US)公布,在美国、欧洲和日本启动了一项(口夫)(口奎)替尼治疗转移性结直肠癌患者的三期注册研究FRESCO-2。首名患者已於昨日(3日)在美国接受给药治疗。
公司指,FRESCO-2是一项在转移性结直肠癌患者中开展的随机、双盲、安慰剂对照的多中心临床试验。研究的主要终点是总生存期。该项大型三期临床试验计划於10个国家的约130个研究中心开展患者招募。美国食品药品监督管理局(FDA)於今年6月授予(口夫)(口奎)替尼快速通道资格,开发用於治疗转移性结直肠癌患者。
根据公司与FDA达成的协议,(口夫)(口奎)替尼的临床数据将可用於支持(口夫)(口奎)替尼用於治疗三线或以上转移性结直肠癌患者的新药上市申请。FRESCO-2的研究设计亦已通过欧洲药品管理局与日本医药品和医疗器械局的审阅及认可。
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