智通财经APP获悉，11月13日，阿斯利康(AZN.US)和第一三共宣布，根据美国FDA的反馈，两家公司已为其联合开发的Trop2靶向抗体偶联药物(ADC)datopotamab deruxtecan(Dato-DXd)递交生物制品许可申请(BLA)，寻求该疗法获加速批准，用以治疗携带表皮生长因子受体(EGFR)突变肿瘤的局部晚期或转移性非小细胞肺癌(NSCLC)成年患者，这些患者之前曾接受过全身性治疗(包括EGFR靶向治疗)。同时，两家公司自愿撤回之前向FDA所递交该疗法用以治疗晚期或转移性非鳞状NSCLC患者的BLA。
据悉，这次所递交的新BLA主要是基于TROPION-Lung05临床2期试验的积极结果，并得到TROPION-Lung01临床3期和TROPION-PanTumor01临床1期试验数据的支持。TROPION-Lung05和TROPION-Lung01试验评估datopotamab deruxtecan对经治EGFR突变NSCLC患者的疗效与安全性。两项试验的汇总分析结果将在即将举行的欧洲肿瘤内科学会(ESMO)亚洲2024年大会上公布。
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