智通财经APP获悉，第一三共(Daiichi Sankyo)公司今日宣布，该公司与阿斯利康(AZN.US)联合开发的抗体偶联药物(ADC)Datroway(datopotamab deruxtecan)已在日本获批，用于治疗接受过化疗后的激素受体(HR)阳性、HER2阴性不可切除或复发性乳腺癌成人患者。这是这款疗法在全球范围内首次获批。值得一提的是，这款ADC被行业媒体Evaluate列为2024年十大潜在重磅研发项目之一。
Datroway的批准基于3期临床试验TROPION-Breast01的结果。试验数据显示，与研究者选择的化疗相比，Datroway将患者的疾病进展或死亡风险降低37%(HR=0.63，95% CI：0.52-0.76；p<0.0001)。Datroway治疗组患者的中位无进展生存期(PFS)为6.9个月，而化疗组为4.9个月。
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