The Food and Drug Administration granted expanded approval to the drug Herceptin. The biologic therapy was approved for use as an adjuvant in combination with doxorubicin, cyclophosphamide, and paclitaxel for treatment of early HER-2 node-positive breast cancer.
Herceptin (trastuzumab), manufactured by Genentech Inc., was first approved by the FDA in 1998 for metastatic breast cancer. The latest approval is based on results from two phase III studies led by the National Surgical Adjuvant Breast and Bowel Project and the North Central Cancer Treatment Group, in collaboration with several National Cancer Institute cooperative groups.
In those studies, 87% of women treated with Herceptin plus the other chemotherapeutics were disease free after 3.5 years, compared with 71% of those treated with the combination minus Herceptin (N. Engl. J. Med. 2005;353:1673–84).
“For women with early-stage HER-2-positive breast cancer, the addition of Herceptin to chemotherapy reduces the relative risk of breast cancer recurrence by approximately half,” Dr. Edward Romond, a professor of medicine in hematology/oncology at the University of Kentucky, Lexington, said in a statement provided by Genentech.
About 212,000 women in the United States will be diagnosed with breast cancer this year. Of those, 25% percent will have HER-2-positive disease.
The approval “is especially good news for women who have breast cancer caused by excessive amounts of HER-2 protein because this cancer typically has a poor prognosis,” Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said in a statement.
Genentech markets Herceptin in the United States. Roche has licensed Herceptin outside of the United States.