FDA批准吉利德的Trodelvy治疗三阴性乳腺癌

2021-04-08 Allan MedSci原创

Trodelvy还显著改善了总体反应和临床受益率。该机构表示,Trodelvy已经获得了优先审查和突破性疗法称号。

三阴性乳癌(Triple-negative breast cancer,TNBC)是指缺乏雌激素受体(ESr或Er)、孕酮受体(Pr)表达与缺乏表皮生长因子受体-2基因(HER)表达的乳癌,临床上一般通过免疫组化确定。

FDA本周三宣布,已批准吉利德科学公司的Trodelvy(sacituzumab govitecan)用于患有不可切除的,局部晚期或转移性三阴性乳腺癌(TNBC)患者,这些患者接受过两种或多种先前的全身疗法治疗。吉利德去年10月以210亿美元的价格从Immunomedics公司收购了靶向Trop-2抗体-药物共轭物Trodelvy,将其添加到自己的肿瘤学产品线中。

初步批准是基于一项单臂II期临床试验,表明Trodelvy的客观缓解率为33.3%,缓解时间为7.7个月。这一最新决定得到了III期ASCENT研究数据的支持,该试验由于疗效是“令人信服”的而被提前终止。

FDA表示,除了Trodelvy达到主要终点,中位无进展生存期为4.8个月(化疗组为1.7个月)之外,ASCENT结果还显示其将总生存期延长至中位11.8个月,而化疗组为6.9个月。此外,Trodelvy还显著改善了总体反应和临床受益率。该机构表示,Trodelvy已经获得了优先审查和突破性疗法称号。

Jefferies&Co.的分析师此前曾暗示Trodelvy可能成为TNBC的首选治疗方法,预计2022年的销售额可能达到4.8亿美元。该药物在2020年第四季度产生了4,900万美元的销售额,目前正在欧盟进行加速审查,以作为TNBC的治疗方法。

 

原始出处:

https://www.firstwordpharma.com/node/1816922?tsid=4

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    2021-11-26 bugit
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    2021-04-10 xlysu
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    2021-04-08 懵懂小初医

    涨知识了

    0

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    2021-04-08 ltxdsr810920

    评论奖励积分

    0

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    2021-04-08 科研科研科研

    吉利德的Trodelvy治疗三阴性乳腺癌

    0

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    2021-04-08 ms3000001642411394

    👍🏻👍🏻

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    2021-04-08 1302a2dfm45暂无昵称

    希望更多绝症都有希望

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    2021-04-08 切菜小能手

    不错不错

    0

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