卫材Halaven获NMPA批准 用于治疗局部晚期或转移性乳腺癌

2019-07-18 newborn 新浪医药新闻

卫材今天宣布,中国药品监督管理局(NMPA)已批准其内部开发的新型抗癌药Halaven(eribulin mesylate,甲磺酸艾瑞布林),用于既往已接受过至少两种化疗方案(包括蒽环素和紫杉烷)的局部晚期或转移性乳腺癌患者。此次批准基于Study 304研究的结果。这是一项在中国开展的多中心、开放标签、随机、平行组III期研究,共入组了530例局部复发或转移性乳腺癌女性患者,这些患者之前接受过至

卫材今天宣布,中国药品监督管理局(NMPA)已批准其内部开发的新型抗癌药Halaven(eribulin mesylate,甲磺酸艾瑞布林),用于既往已接受过至少两种化疗方案(包括蒽环素和紫杉烷)的局部晚期或转移性乳腺癌患者。


此次批准基于Study 304研究的结果。这是一项在中国开展的多中心、开放标签、随机、平行组III期研究,共入组了530例局部复发或转移性乳腺癌女性患者,这些患者之前接受过至少2种、至多5种化疗方案(包括一种蒽环类和一种紫杉类),评估了Havalen与长春瑞滨(vinorelbine)的疗效和安全性。研究中,患者随机分配接受Halaven(1.4mg/m2,第1天和第8天静脉输注)或长春瑞滨(25mg/m2,第1天、第8天、第15天静脉输注)治疗,21天为一个周期,直至病情进展。主要终点是无进展生存期(PFS)。

结果显示,根据独立影像学检查,与长春瑞滨治疗组相比,Havalen治疗组PFS具有统计学意义的显着改善(HR=0.80,95%CI:0.65-0.98,p=0.036),达到了研究的主要终点。安全性方面,Halaven治疗组最常见的不良事件包括白细胞计数减少、中心粒细胞计数减少、天门冬氨酸转氨酶升高、丙氨酸转氨酶升高和贫血,与Halaven已知的副作用一致。


Havalen是一种合成的大田软海绵素(halichondrin B)类似物,这是一种微管动力学抑制剂,具有新颖的作用机制。Halichondrin B是一种从生长在日本沿海的黑色海绵上发现的物质,能够有效治疗肿瘤。除了抑制微管动力学生长的作用机制外,非临床研究还表明,Halaven对肿瘤微环境具有独特的作用,如增加肿瘤核心区域的血管灌注和渗透性、促进上皮状态、降低乳腺癌细胞的迁移能力。

Havalen由卫材发现和开发,乳腺癌治疗方面,已在全球超过65个国家获得批准。此外,该药也已获全球40多个国家批准治疗软组织肉瘤(STS)。当前,卫材正在调查Halaven治疗多种类型肿瘤的潜力,包括膀胱癌、三阴性乳腺癌、HER2阴性乳腺癌等。

参考来源:ANTICANCER AGENT HALAVEN® APPROVED FOR TREATMENT OF LOCALLY ADVANCED OR METASTATIC BREAST CANCER IN CHINA

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    2020-01-02 cathymary
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    2019-07-20 chg122
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    2019-07-18 phoebeyan520

    学习,了

    0

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乳腺癌是目前女性最常见的恶性肿瘤,HER2阳性的乳腺癌占全部乳腺癌的25%左右,这种类型的乳腺癌进展快、易复发转移且预后不良。而靶向HER2基因的靶向药物可以明显改善患者的预后,延长生命并提高生活质量。近几年,HER2靶向药取得了不小的进展,乳腺癌患者该如何选用呢,我们一起来看看ASCO会议上的数据报道。