阿斯利康(AZN.US)潜在重磅ADC获突破性疗法认定

智通财经12-10

智通财经APP获悉，阿斯利康(AZN.US)和第一三共宣布，美国FDA授予其Trop2靶向抗体偶联药物(ADC)datopotamab deruxtecan(Dato-DXd)突破性疗法认定(BTD)，用于治疗携带局部晚期或转移性表皮生长因子受体突变(EGFRm)的非小细胞肺癌(NSCLC)成人患者，这些患者在接受EGFR酪氨酸激酶抑制剂(TKI)和铂类化疗后疾病仍出现进展。根据新闻稿，这是datopotamab deruxtecan首次获得突破性疗法认定。

此次FDA授予突破性疗法认定主要是基于TROPION-Lung05临床2期试验数据，并加上TROPION-Lung01临床3期试验的支持性数据。今年美国临床肿瘤学会(ASCO)年会中所公布的TROPION-Lung05试验的部分结果显示，18名具有目标脑部病灶的经治局部晚期或转移性NSCLC患者的颅内(IC)客观缓解率(ORR)为22%(95% CI：6–48)，IC疾病控制率(DCR)为72%(95% CI：47–90)。18例患者中有10名(56%)出现脑部肿瘤直径总和缩小。

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