ROCKVILLE, Md., Nov. 17 -- The FDA said today it has expanded approval of Herceptin (trastuzumab) to include its use as adjuvant therapy in the treatment of early stage HER2 positive breast cancer.
ROCKVILLE, Md., Nov. 17 -- The FDA said today it has expanded approval of Herceptin (trastuzumab) to include its use as adjuvant therapy in the treatment of early-stage HER2 positive breast cancer.
Herceptin, already approved for metastatic breast cancer, is now also indicated for women who have undergone lumpectomy or mastectomy for treatment of tumors confined to the breast or lymph nodes.
A National Cancer Institute-sponsored multicenter clinical trials group conducted the two studies leading to this new indication. Patients in both trials received standard chemotherapy after surgery for breast cancer; and approximately half were also given Herceptin.
In the light of disease-free results at three years, the NCI ended the studies early. The results were reported at the American Society of Clinical Oncology meeting n 2005 and later published in the New England Journal of Medicine.
The combined trials, which included information on nearly 4,000 women, found that 87% who followed surgery with chemotherapy plus Herceptin were disease-free three years later versus 75% of women treated with chemotherapy alone.
The FDA noted that it is too soon to know whether Herceptin combined with chemotherapy will increase the cure rate or lower the risk of death from breast cancer.
About 25% of breast cancers are caused by tumors that over-express HER2 and it is women with these malignancies who can benefit from Herceptin therapy.
Steven Galson, M.D., M.P.H, director of the FDA's Center for Drug Evaluation and Research, said the expanded indication for Herceptin was "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."
The most serious side effect of Herceptin is heart failure that requires medical treatment. Because of the risk of heart disease, only certain patients should receive the drug, including:
Less common but serious side effects include infusion reactions that rarely are accompanied by lung problems, low white blood counts, and low red blood cell counts.
Herceptin is manufactured by Genentech.