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Introduction
Data from the landmark study that earned Herceptin® approval in 1998 by the Food and Drug Administration (FDA) for the treatment of metastatic breast cancer were published in the New England Journal of Medicine on March 15, 2001.
The study shows that Herceptin increases overall response rate to treatment, slows progression of metastatic breast disease, and increases overall survival for patients given the drug along with standard chemotherapy compared to chemotherapy alone. The newly published report extends the study's followup through October 1999.
Herceptin (trastuzumab) is a monoclonal antibody designed in the laboratory that targets a genetic defect found in some cancer cells. "This is the beginning of an important new era in cancer treatment, since many more such targeted therapies are now undergoing clinical evaluation," wrote Elizabeth Eisenhauer, M.D., Queens University, in an editorial accompanying the journal article.
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