Herceptin®
(trastuzumab)
About Herceptin
Herceptin is a humanized monoclonal antibody currently indicated for first-line and second-line treatment of metastatic HER2 over-expressing breast cancer in the US and EU, as adjuvant treatment in node-positive HER2-positive breast cancer and adjuvant node-negative HER2-positive breast cancer in the US, and as adjuvant HER2-positive breast cancer in the EU. Breast cancer is characterized by the uncontrolled growth of lobular or ductal cells. Since its initial approval in 1998, Herceptin has become the “gold standard” of treatment for HER2-positive breast cancer. Recent studies also show that Herceptin may be efficacious in several other cancers, including cancer of the stomach. It is marketed in the United States by Genentech, in Japan by Chugai and in the rest of the world by Roche.
How Herceptin Works
Herceptin prevents the over-expression of the HER2 protein. This is important because HER2-positive breast cancer is a more aggressive form of the disease with a greater likelihood of recurrence, poorer prognosis and decreased survival than the HER2-negative form of the disease.
Current Indications
Herceptin was approved in:
- September 1998 for first-line and second-line metastatic HER2-positive breast cancer in the US and August 2000 in the EU for first-line and second-line metastatic HER2-positive cancer. May 2006 as adjuvant therapy for HER2-positive breast cancer in the EU.
- November 2006 as adjuvant therapy for node-positive HER2-positive breast cancer in the US.
- January 2008 as adjuvant therapy for node-negative HER2-positive breast cancer in the US.
Clinical Trials
- Adjuvant HER2-positive breast cancer (HERA 2-year treatment)