Description Herceptin® (Trastuzumab) is a humanized antibody designed to target and block the function of HER2 protein overexpressing cells. It inhibits cancer cell division and growth by seeking out extra HER2 protein receptors on the surface of cancer cells, attaching itself to these areas and preventing the HER2 growth response.

Development Status Phase III clinical trials are ongoing evaluating Herceptin in combination with Avastin for first-line HER2-positive metastatic breast cancer and for adjuvant HER2-positive breast cancer; evaluating Herceptin plus chemotherapy in combination with pertuzumab for first-line HER2-positive metastatic breast cancer; and evaluating two years of Herceptin administration for adjuvant HER2-positive breast cancer (HERA 2-year).

Approved Uses

• In September 1998, the U.S. Food and Drug Administration (FDA) approved Herceptin for use in patients with metastatic breast cancer whose tumors overexpress the HER2 protein. It is indicated for treatment of patients both as first-line therapy in combination with paclitaxel and as a single agent in second- and third-line therapy.
• In November 2006, the FDA approved Herceptin as part of a treatment regimen containing doxorubicin, cyclophosphamide, and paclitaxel for the adjuvant treatment of patients with HER2-overexpressing, node-positive breast cancer.
• In January 2008, the FDA approved Herceptin as a single agent for the adjuvant treatment of HER2-overexpressing node-negative (ER/PR-negative or with one high-risk feature) or node-positive breast cancer, following multi-modality anthracycline-based therapy.
• In May 2008, the FDA approved Herceptin for adjuvant treatment of patients with HER2-overexpressing, node-positive and high-risk node-negative breast cancer as part of:
  • a non-anthracycline treatment regimen containing docetaxel and carboplatin, and
  • with docetaxel following an anthracycline treatment regimen containing doxorubicin and cyclophosphamide.

BOXED WARNINGS and Important Safety Information Patients treated with Herceptin may experience serious or life-threatening side effects, including:

• Heart problems, including those without symptoms (reduced heart function) and those with symptoms (congestive heart failure)
• Serious infusion reactions and lung problems
• Fatal infusion reactions

Worsening of low white blood cell counts associated with chemotherapy has also occurred. Herceptin can cause low amniotic fluid levels and harm to the fetus when taken by a pregnant woman.

The most common side effects associated with Herceptin were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, shortness of breath, rash, low white and red blood cells, and muscle pain.

For Herceptin full prescribing information, including Boxed WARNINGS and additional important safety information, please visit http://www.herceptin.com.

Additional Information on Clinical Trials For inquiries about our clinical trials, please submit a request through our information request form or call (888) 662-6728.

National Institutes of Health Website: www.clinicaltrials.gov

August 2009