USES FOR AND ARTICLE OF MANUFACTURE INCLUDING HER2 DIMERIZATION INHIBITOR PERTUZUMAB
    4.
    发明申请
    USES FOR AND ARTICLE OF MANUFACTURE INCLUDING HER2 DIMERIZATION INHIBITOR PERTUZUMAB 审中-公开
    用于制造和包含二维抑制剂PERTUZUMAB的制品

    公开(公告)号:US20130095172A1

    公开(公告)日:2013-04-18

    申请号:US13649591

    申请日:2012-10-11

    Abstract: The present application describes uses for and articles of manufacture including Pertuzumab, a first-in-class HER2 dimerization inhibitor. In particular, the application describes methods for extending progression free survival in a HER2-positive breast cancer patient population; combining two HER2 antibodies to treat HER2-positive cancer without increasing cardiac toxicity; treating early-stage HER2-positive breast cancer; treating HER2-positive cancer by co-administering a mixture of Pertuzumab and Trastuzumab from the same intravenous bag; treating HER2-positive metastatic gastric cancer; treating HER2-positive breast cancer with Pertuzumab, Trastuzumab and Vinorelbine; treating HER2-positive breast cancer with Pertuzumab, Trastuzumab and aromatase inhibitor; and treating low HER3 ovarian, primary peritoneal, or fallopian tube cancer. It also describes an article of manufacture comprising a vial with Pertuzumab therein and a package insert providing safety and/or efficacy data thereon; a method of making the article of manufacture; and a method of ensuring safe and effective use of Pertuzumab related thereto. In addition the application describes an intravenous (IV) bag containing a stable mixture of Pertuzumab and Trastuzumab suitable for administration to a cancer patient.

    Abstract translation: 本申请描述了包括Pertuzumab(一流的HER2二聚抑制剂)的用途和制品。 特别地,本申请描述了在HER2阳性乳腺癌患者群体中扩展无进展生存的方法; 结合两种HER2抗体治疗HER2阳性癌症而不增加心脏毒性; 治疗早期HER2阳性乳腺癌; 通过从相同的静脉内袋中共同施用Pertuzumab和曲妥珠单抗的混合物来治疗HER2阳性癌症; 治疗HER2阳性转移性胃癌; 用Pertuzumab,曲妥珠单抗和长春瑞滨治疗HER2阳性乳腺癌; 用Pertuzumab,曲妥珠单抗和芳香酶抑制剂治疗HER2阳性乳腺癌; 并治疗低HER3卵巢,原发性腹膜或输卵管癌。 它还描述了一种制造方法,其中包括其中具有Pertuzumab的小瓶和在其上提供安全性和/或功效数据的包装插页; 制造该制品的方法; 以及确保安全有效地使用与之相关的Pertuzumab的方法。 此外,本申请描述了一种静脉内(IV)袋,其中含有适用于给予癌症患者的Pertuzumab和曲妥珠单抗的稳定混合物。

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