荣昌生物“维迪西妥单抗”获批治疗乳腺癌肝转移患者

医药魔方Info
09 May

5月9日,国家药监局网站显示,荣昌生物的维迪西妥单抗(商品名:爱地希)获批新适应症,用于治疗存在肝转移的HER2阳性晚期乳腺癌患者。此次批准主要是基于III期RC48-C006研究的积极结果。这是全球首个证实HER2 ADC在HER2阳性存在肝转移的晚期乳腺癌患者中取得阳性结果的确证性III期研究。本研究最终分析结果显示,截至2023年12月31日(中位随访17.2个月),根据独立审查委员会(...

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