智通财经APP获悉,2月21日,CDE网站显示,阿斯利康(AZN.US)的PD-L1单抗度伐利尤单抗在华申报新适应症。根据阿斯利康2024年财报,此次申报的适应症为联合替西木单抗和标准治疗一线治疗无致敏表皮生长因子受体(EGFR)突变或间变性淋巴瘤激酶(ALK)基因组肿瘤畸变的转移性非小细胞肺癌(NSCLC)成年患者。
此次上市申请是基于III期POSEIDON研究的积极结果。该研究在1013例EGFR/ALK野生型转移性NSCLC患者中评估了度伐利尤单抗(1500mg)+替西木单抗(75mg)±标准治疗(铂类化疗)对比标准治疗的疗效和安全性。
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