博度曲妥珠单抗:已获批二线及以上治疗乳腺癌,涵盖三线适应症人群

医药笔记
Dec 12, 2025

▎Armstrong近日,据国家药监局公开审批信息显示,科伦博泰自主研发的 HER2 靶向 ADC 药物博度曲妥珠单抗(舒泰莱 ®)治疗三线HER2 阳性乳腺癌的上市申请审批已终止。值得注意的是,今年10月,博度曲妥珠单抗已获批治疗二线及以上HER2 阳性乳腺癌,成为首个覆盖该适应症二线及以上全人群的国产HER2 ADC药物,为中国晚期 HER2 阳性乳腺癌患者带来全新治疗选择。据悉,在博度曲妥珠...

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