The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Food and Drug Administration today approved Perjeta (pertuzumab), a new anti-HER2 therapy, to treat patients with HER2-positive late-stage (metastatic) breast cancer.
Intended for patients who have not received prior treatment for metastatic breast cancer with an anti-HER2 therapy or chemotherapy, Perjeta is combined with trastuzumab, another anti-HER2 therapy, and docetaxel, a type of chemotherapy.
HER2 is a protein involved in normal cell growth. It is found in increased amounts on some types of cancer cells (HER2-positive), including some breast cancers. In these HER2-positive breast cancers, the increased amount of the HER2 protein contributes to cancer cell growth and survival.
Perjeta is a humanized monoclonal antibody, manufactured through biotechnology methods. It is administered intravenously and is believed to work by targeting a different part of the HER-protein than trastuzumab, resulting in further reduction in growth and survival of HER2-positive breast cancer cells.
For more information please visit: Perjeta
This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO FDA (1-888-463-6332) or (301) 796-3400 from 8:00 am - 4:30 pm Monday - Friday. You can also email us at druginfo@fda.hhs.gov.
- For additional drug information, please visit the DDI Web page.
- For up-to-date drug information, follow the FDA’s Division of Drug Information on Twitter: FDA_Drug_Info
- This service is provided to you at no charge by the U.S. Food & Drug Administration (FDA).