USES FOR AND ARTICLE OF MANUFACTURE INCLUDING HER2 DIMERIZATION INHIBITOR PERTUZUMAB

摘要

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.