阿斯利康(AZN.US)PD-L1+CTLA-4組合在華申報上市一線治療NSCLC

智通財經

02-21

智通財經APP獲悉，2月21日，CDE網站顯示，阿斯利康(AZN.US)的PD-L1單抗度伐利尤單抗在華申報新適應症。根據阿斯利康2024年財報，此次申報的適應症爲聯合替西木單抗和標準治療一線治療無致敏表皮生長因子受體(EGFR)突變或間變性淋巴瘤激酶(ALK)基因組腫瘤畸變的轉移性非小細胞肺癌(NSCLC)成年患者。

此次上市申請是基於III期POSEIDON研究的積極結果。該研究在1013例EGFR/ALK野生型轉移性NSCLC患者中評估了度伐利尤單抗(1500mg)+替西木單抗(75mg)±標準治療(鉑類化療)對比標準治療的療效和安全性。

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