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诺华的MET抑制剂卡马替尼治疗非小细胞肺癌,获得FDA授予优先审查

2020-02-14 不详 MedSci原创

诺华制药宣布,美国食品药品监督管理局(FDA)接受了MET抑制剂卡马替尼(INC280)的新药申请(NDA)并给予了优先审查,用于一线治疗和先前治疗过的局部晚期或转移性MET外显子14跳跃(METex14)突变的非小细胞肺癌(NSCLC)患者。

诺华制药宣布,美国食品药品监督管理局(FDA)接受了MET抑制剂卡马替尼(INC280)的新药申请(NDA)并给予了优先审查,用于一线治疗和先前治疗过的局部晚期或转移性MET外显子14跳跃(METex14)突变的非小细胞肺癌NSCLC)患者。

该公司表示,如果获得批准,该药物将成为第一种针对METex14突变晚期肺癌的治疗方法,这种晚期肺癌预后特别差。

就目前情况而言,尽管NSCLC约占肺癌诊断的85%,但尚无针对性地靶向METex14突变的晚期NSCLC的批准疗法。

全球药物研发主管兼首席医学官John Tsai说:" GEOMETRY mono-1试验的结果清楚地表明METex14是致癌驱动因素,我们受到启发将卡马替尼(可能是第一种METex14靶向疗法)带给患者。"

这家制药业巨头证实,GEOMETRY mono-1 II期研究的结果支持了卡帕替尼的NDA提交,该研究表明,未接受过治疗的患者和先前接受过治疗的患者的总缓解率分别为67.9%和40.6%。

肺癌是全球最常见的癌症,2018年有210万例新病例,180万例死亡。NSCLC约占肺癌诊断的85%,包括已知的致癌突变。

原始出处:


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    2020-02-20 jklm09
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    2020-05-19 一闲
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