Limertinib: First Approval

doi:10.1007/s40265-025-02184-y

2025-06-23

PRE

Arnold Lee *

DOI：10.1007/s40265-025-02184-y

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Limertinib (Aoyixin)是一种口服有效的第三代表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI），已开发用于非小细胞肺癌（NSCLC）的治疗。在临床试验中，limertinib在T790M门keeper突变阳性的患者中显示出疗效。Limertinib于2025年1月在中国首次获得批准，用于治疗接受EGFR TKI治疗后疾病进展且EGFR T790M突变阳性的局部晚期或转移性NSCLC成人患者。2025年4月，limertinib在中国也获批准用于EGFR第19外显子缺失或第21外显子L858R突变阳性的局部晚期或转移性NSCLC成人患者的一线治疗。本文总结了导致该首次批准的limertinib开发历程中的重要里程碑。

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