March 8, 2009

FDA Approves Herceptin® for Use as Single Agent in Early Breast Cancer


FDA Approves Herceptin® for Use as Single Agent in Early Breast Cancer

The United States Food and Drug Administration (FDA) has approved the targeted agent Herceptin® (trastuzumab) for use as a single agent in the treatment of early, HER2-positive breast cancer. The new indication specifies use of Herceptin in patients who have received prior therapy with multiple modalities including chemotherapy with anthracyclines (including Adriamycin® or Ellence®).

The indication also specifies that patients with either node-positive (cancer spread to the lymph nodes under the arm) or node-negative (no spread to lymph nodes under the arm) are eligible for treatment with Herceptin as a single agent. However, to qualify for Herceptin patients with node-negative breast cancer must also have at least one of the following characteristics: be hormone-receptor negative; be grade 2 or 3 (moderately or highly aggressive); be greater than 2 centimeters in diameter; and/or the patient must be less than 35 years of age.

The human epidermal growth factor receptor 2 (HER2) is part of a biological pathway involved in growth and spread of cancer cells. Several types of cancers overexpress HER2, including approximately 25–30% of breast cancers. These cancers are referred to as HER2-positive. Overexpression of HER2 often results in uncontrolled growth and spread of cancer cells. All breast cancer patients should now be tested for HER2 status before beginning treatment.

Herceptin is targeted against HER2 and helps to slow or stop the spread of cancer cells that over express HER2. Herceptin is often used in combination with chemotherapy for the treatment of breast cancer that over expresses HER2. The FDA has now approved Herceptin for use as a single agent in the treatment of early HER2-positive breast cancer.

The FDA approval of Herceptin for this indication was prompted by results from a clinical trial referred to as the HERA trial. Patients in this trial had early, HER2-positive breast cancer and were treated either with or without Herceptin in combination with other therapies. Patients treated with the addition of Herceptin had a 46% reduction in recurrences compared with those treated with chemotherapy only.

Congestive heart failure (irreversible heart damage) occurred in 2% of patients treated with Herceptin compared with only 0.3% of patients who did not receive Herceptin.

Patients with early, HER2-positive breast cancer may wish to speak with their physician regarding their individual risks and benefits of treatment with Herceptin.

Reference: Genentech. Herceptin Adjuvant Approval. Available at: Accessed January 2008.

Related News:

Heart Problems Infrequent in Women Treated with Herceptin® (08/14/2007)

Herceptin Improves Survival in HER2-positive Early Breast Cancer (1/8/2007)

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