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Use of HER2 dimerization inhibitor pertuzumab and articles of manufacture containing pertuzumab

机译:HER2二聚化抑制剂帕妥珠单抗的用途和含有帕妥珠单抗的制品

摘要

This application describes the use of pertuzumab, a first-in-class HER2 dimerization inhibitor, and articles of manufacture comprising it. In particular, the present application relates to a method for extending progression-free survival in a population of HER2-positive breast cancer patients; for combining two HER2 antibodies to treat HER2-positive cancer cancer without increasing cardiotoxicity A method for treating early HER2-positive breast cancer; a method for treating HER2-positive cancer by co-administering a mixture of pertuzumab and trastuzumab from the same intravenous drip bag; for treating HER2-positive metastatic gastric cancer A method for treating HER2-positive breast cancer with pertuzumab, trastuzumab and vinorelbine; a method for treating HER2-positive breast cancer with pertuzumab, trastuzumab and an aromatase inhibitor; and low HER3 ovarian cancer, primary peritoneal cancer or fallopian tube A method for treating cancer is described. The application also provides a product comprising a vial comprising pertuzumab and a package insert providing safety and / or efficacy data; a method for producing said product; and the safe and effective use of pertuzumab associated therewith. Describe how to ensure. In addition, this application describes an intravenous (IV) bag containing a stable mixture of pertuzumab and trastuzumab suitable for administration to cancer patients.
机译:该申请描述了帕妥珠单抗(一种一流的HER2二聚抑制剂)的用途,以及包含它的制品。特别地,本申请涉及一种用于在HER2阳性乳腺癌患者群体中延长无进展生存的方法。用于在不增加心脏毒性的情况下结合两种HER2抗体来治疗HER2阳性的癌症的方法一种治疗早期HER2阳性的乳腺癌的方法;通过从同一静脉滴注袋中共同施用帕妥珠单抗和曲妥珠单抗的混合物来治疗HER2阳性癌症的方法;用于治疗HER2阳性转移性胃癌的方法用帕妥珠单抗,曲妥珠单抗和长春瑞滨治疗HER2阳性乳腺癌。一种用帕妥珠单抗,曲妥珠单抗和芳香酶抑制剂治疗HER2阳性乳腺癌的方法;和低HER3卵巢癌,原发性腹膜癌或输卵管描述了一种治疗癌症的方法。本申请还提供了一种产品,该产品包括包含帕妥珠单抗的小瓶和提供安全性和/或功效数据的包装说明书;生产所述产品的方法;以及安全有效地使用与之相关的帕妥珠单抗。描述如何确保。另外,该申请描述了一种静脉(IV)袋,其包含适合于向癌症患者施用的帕妥珠单抗和曲妥珠单抗的稳定混合物。

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