强生(JNJ.US)宣布EGFR/c-MET双抗“埃万妥单抗”在国内获批一项新适应症

智通财经
Aug 08, 2025

智通财经APP获悉,8月8日,强生(JNJ.US)宣布EGFR/c-MET双抗“埃万妥单抗”(Amivantamab)在国内获批一项新适应症,联合兰泽替尼适用于携带表皮生长因子受体(EGFR)19号外显子缺失或21号外显子L858R置换突变的局部晚期或转移性非小细胞肺癌(NSCLC)成人患者的一线治疗。

2025年2月,该药首次在国内获批,用于EGFRex20ins突变NSCLC一线治疗。2025年4月,该药在国内获批一项新适应症,联合化疗用于EGFRTKI经治后局部晚期或转移性NSCLC患者治疗。本次是埃万妥单抗在国内获批的第3项适应症。

埃万妥单抗最早于2021年5月在美国首次获得加速批准上市。迄今,围绕非小细胞肺癌这一重磅癌种,埃万妥单抗在全球范围内已获批4项适应症

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