艾力斯“伏美替尼”新适应症拟优先审评

Insight数据库2025-07-08

7 月 8 日，药监局官网显示，艾力斯甲磺酸伏美替尼片拟纳入优先审评品种，用于既往经含铂化疗治疗时或治疗后出现疾病进展，或不耐受含铂化疗，并且经检测确认存在表皮生长因子受体（EGFR）20 外显子插入突变的局部晚期或转移性 NSCLC 成人患者的治疗。这是该产品第三次被纳入优先审评。该适应症基于一项单臂临床试验结果获得的附条件批准，完全批准将取决于确证性临床试验的临床获益。来源：CDE 官网伏美...

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