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云顶新耀(01952.HK)旗下治疗转移性乳腺癌药物临床试验申请获批
阿思达克 11-02 08:25
云顶新耀(01952.HK)公布,中国国家药品监督管理局通过了Trodelvy(sacituzumab govitecan)用於治疗至少两种既往化疗方案治疗失败的激素受体阳性/人表皮生长因数受体2阴性(「HR+╱HER2-」)转移性乳腺癌(「mBC」)的临床试验申请(「CTA」)。

随着临床试验申请的获批,公司计划启动3期注册临床试验EVER-132-002,这项试验旨在评估和比较sacituzumab govitecan与医生选择的治疗(TPC)在接受过至少2种但不超过4种既往化疗方案的HR/HER2-转移性乳腺癌的亚洲患者的有效性和安全性。该试验将在内地、台湾及韩国招募大约330名HR+/HER2-转移性乳腺癌患者。

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