智通财经APP获悉，1月2日，国家药监局网站显示，阿斯利康(AZN.US)的奥希替尼新适应症上市申请正式获得批准，用于治疗在接受含铂根治性放化疗后未出现疾病进展、具有表皮生长因子受体(EGFR)外显子19缺失(Ex19del)或外显子21(L858R)置换突变的局部晚期不可切除(III期)非小细胞肺癌(NSCLC)成人患者。

据悉，奥希替尼是一种不可逆的第三代表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKI)，具有抗CNS转移的临床活性。该产品已在国内获批4项适应症，分别为：1)往经EGFR TKI治疗时或治疗后出现疾病进展，并且经检测确认存在EGFR T790M突变阳性的局部晚期或转移性NSCLC成人患者；2)一线治疗Ex19del或L858R置换突变的NSCLC患者；3)EGFR敏感突变NSCLC成人患者肿瘤切除术后的辅助治疗；4)联合培美曲塞和铂类化疗药物一线治疗具有EGFR外显子19缺失或外显子21(L858R)置换突变的局部晚期或转移性NSCLC成人患者。  

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