Sreedhara Alavattam,Lukas C. Amler,Mark C. Benyunes,Emma L. Clark,Christina H. de Toledo Pelizon,Zephania W. Kwong Glover,Lada Mitchell,Jayantha Ratnayake,Graham A. Ross,Ru-Amir Walker
申请号:
US13649591
公开号:
US20130095172A1
申请日:
2012.10.11
申请国别(地区):
US
年份:
2013
代理人:
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.