FDA对阿斯利康肿瘤治疗的Tagrisso进行优先审查

2017-12-19 MedSci MedSci原创

美国FDA已经开始对阿斯利康公司的一线非小细胞肺癌（NSCLC）的Tagrisso进行优先审查，并于2018年上半年获得批准。第三代EGFR抑制剂Tagrisso(osimertinib)已经被批准作为该类药物的后续治疗，包括AZ的易瑞沙(gefitinib)和罗氏的Tarceva(erlotinib)，但扩大到一线使用可以显着提高其销售潜力。它也在11月向欧盟递交了一线用药申请，目前正在审核中。

美国FDA已经开始对阿斯利康公司的一线非小细胞肺癌（NSCLC）的Tagrisso进行优先审查，并于2018年上半年获得批准。

第三代EGFR抑制剂Tagrisso(osimertinib)已经被批准作为该类药物的后续治疗，包括AZ的易瑞沙(gefitinib)和罗氏的Tarceva(erlotinib)，但扩大到一线使用可以显着提高其销售潜力。它也在11月向欧盟递交了一线用药申请，目前正在审核中。

Tagrisso已经成为AZ产品中发展最快的新产品之一，今年前九个月销售额增长了138％，达到6.51亿美元，AZ希望将该药物定位为NSCLC新的一线用药，这有利于推动其成为畅销产品。它已经超过易瑞沙，易瑞沙同期带来3.98亿美元收益。

支持这项新应用的数据来自于转移性NSCLC患者的FLAURA试验，这些患者的肿瘤有EGFR突变(exon 19缺失或exon 21(L858R)替代突变)，这表明与Iressa和Tarceva相比，Tagrisso延长了无进展生存期(PFS)。

服用Tagrisso的患者的PFS为18.9个月，而接受其他药物的患者为10.2个月，降低54％，客观缓解率分别为80％和76％。

AZ认为，肿瘤进展时间的延长对于患者来说具有临床意义，应该足以支持批准，尽管分析人员建议为确保在一线NSCLC药中开具商业上的成功，Tagrisso可能需要积极的总生存数据。

在美国，肿瘤学家似乎已经准备接受这种药物作为一种新的一线选择，然而，截至9月，全美癌症综合癌症网络临床实践指南在肿瘤学中得到了更新，包括使用Tagrisso治疗转移性EGFR突变阳性的NSCLC患者的一线治疗。

有人建议Tagrisso应该被用于二线治疗，因为这样做有两种治疗方法--一线药物还没有被证明能够对AZ的新药产生耐药性。另一方面，其他人则认为这样做会否定患者最好的一线治疗方案，这是不公平的，因为大多数一线患者（最多一半）不会发展为EGFR突变。

原文出处：http：//www.pmlive.com/pharma_news/clock_starts_ticking_on_azs_first-line_lung_cancer_filing_in_us_1214772

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2017-12-21 wumeihua88

#肿瘤治疗#

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2017-12-21 tsing_hit

#Tagrisso#

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2017-12-21 yxch37

#优先审查#

84 0
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2017-12-21 Drhzm308

谢谢学习了.

104 0
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2017-12-20 小霸王汪汪

学习了

118 0
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2017-12-20 龙胆草

学习谢谢分享

117 0
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2017-12-20 smartxiuxiu

好!

119 0
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topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2017/04/21/72142930668371951a41ef4ea4b233e6.jpg, createdBy=dcbc1715228, createdName=刘煜, createdTime=Wed Dec 20 05:48:27 CST 2017, time=2017-12-20, status=1, ipAttribution=)]
2017-12-20 明月清辉

谢谢分享.学习了

133 0
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topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2017/04/21/72142930668371951a41ef4ea4b233e6.jpg, createdBy=dcbc1715228, createdName=刘煜, createdTime=Wed Dec 20 05:48:27 CST 2017, time=2017-12-20, status=1, ipAttribution=)]
2017-12-20 榄枷檬

谢谢分享

60 0
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topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2017/04/21/72142930668371951a41ef4ea4b233e6.jpg, createdBy=dcbc1715228, createdName=刘煜, createdTime=Wed Dec 20 05:48:27 CST 2017, time=2017-12-20, status=1, ipAttribution=)]
2017-12-20 刘煜

谢谢分享.阅读

61 0

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