The U.S. Food and Drug Administration (FDA) has expanded the approved use of Herceptin, a biological cancer drug. The new indication is for Herceptin, in combination with other cancer drugs, for the treatment of HER2 positive breast cancer after surgery (lumpectomy or mastectomy).
FDA granted priority review to the supplemental application for Herceptin.
Herceptin is a targeted therapy against the HER2 protein on cancer cells. When an excessive amount of HER2 protein is present, it causes cancer cells to grow more rapidly and standard chemotherapy may be less effective. In 1998, FDA approved Herceptin for the treatment of metastatic breast cancer (cancer that has spread to other sites in the body). Today's approval expands its use to women with cancer only in the breast or lymph nodes which has been removed with surgery. Herceptin should only be prescribed for women diagnosed with HER2 positive breast cancer.
"This is especially good news for women who have breast cancer caused by excessive amounts of the HER-2 protein because this cancer typically has a poor prognosis," said Dr. Steven Galson, Director for FDA's Center for Drug Evaluation and Research.
The two studies leading to this new approved indication were conducted by the National Cancer Institute-sponsored Cooperative Groups, a multicenter clinical trials group. Patients in both trials received standard chemotherapy after surgery for breast cancer; approximately half the patients were also given Herceptin. The results from both trials, which included information on nearly 4,000 women, were combined and analyzed in 2005.