Herceptin is approved for the treatment of early breast cancer (EBC) that is Human Epidermal growth factor Receptor 2-positive (HER2+) and has spread into the lymph nodes. In the case of HER2+ EBC that has not spread to the lymph nodes, it must meet the following condition: the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high-risk feature.* Herceptin is also approved for the treatment of HER2+ breast cancer that has spread to other parts of the body (metastatic breast cancer).
*High risk is defined as ER/PR-positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.
You must have your cancer tested to determine if your cancer is HER2-positive (or HER2+) before you can start treatment with Herceptin.
†Based upon average weight and vials sold.
‡Herceptin was first FDA approved in 1998 to treat HER2+ metastatic breast cancer. In 2006, the FDA approved Herceptin to treat HER2+ early breast cancer. In 2010, the FDA approved Herceptin to treat HER2+ metastatic stomach cancer.
See some things to keep in mind with Herceptin.
See some things to keep in mind with Herceptin.
Herceptin Prescribing Information. Genentech, Inc. February 2021.
Herceptin Prescribing Information. Genentech, Inc. February 2021.
FDA Approval Letter. Herceptin. September 25, 1998. At: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/trasgen092598L.pdf. Accessed June 24, 2019.
FDA Approval Letter. Herceptin. September 25, 1998. At: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/trasgen092598L.pdf. Accessed June 24, 2019.
Jackisch C. HER-2-positive metastatic breast cancer: optimizing trastuzumab-based therapy. Oncologist. 2006;11(suppl 1):34-41. At: http://theoncologist.alphamedpress.org/content/11/suppl_1/34.full.pdf+html. Accessed June 24, 2019.
Jackisch C. HER-2-positive metastatic breast cancer: optimizing trastuzumab-based therapy. Oncologist. 2006;11(suppl 1):34-41. At: http://theoncologist.alphamedpress.org/content/11/suppl_1/34.full.pdf+html. Accessed June 24, 2019.
Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001;344(11):783-792. At: https://www.nejm.org/doi/full/10.1056/NEJM200103153441101. Accessed June 24, 2019.
Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001;344(11):783-792. At: https://www.nejm.org/doi/full/10.1056/NEJM200103153441101. Accessed June 24, 2019.
Marty M, Cognetti F, Maraninchi D, et al; for the M77001 Study Group. Randomized Phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2–positive metastatic breast cancer administered as first-line treatment: the M77001 Study Group. J Clin Oncol. 2005;23(19):4265-4274. At: https://ascopubs.org/doi/pdf/10.1200/JCO.2005.04.173. Accessed June 24, 2019.
Marty M, Cognetti F, Maraninchi D, et al; for the M77001 Study Group. Randomized Phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2–positive metastatic breast cancer administered as first-line treatment: the M77001 Study Group. J Clin Oncol. 2005;23(19):4265-4274. At: https://ascopubs.org/doi/pdf/10.1200/JCO.2005.04.173. Accessed June 24, 2019.
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