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Breast Cancer

U.S. FDA approves Herceptin for adjuvant treatment of HER2-positive node-positive breast cancer

Published in Cancer Weekly, December 19th, 2006

Genentech, Inc. (DNA) announced that the U.S. Food and Drug Administration (FDA) approved Herceptin (Trastuzumab) as part of a treatment regimen containing doxorubicin, cyclophosphamide, and paclitaxel, for the adjuvant treatment of HER2-positive node-positive breast cancer.

The FDA approval was based on data from an interim joint analysis of more than 3,500 patients enrolled in two Phase III clinical trials. These results showed that the addition of Herceptin to standard adjuvant therapy significantly reduced the risk of breast cancer recurrence, the primary endpoint of the studies, by 52% (or a hazard ratio of 0.48) in women with HER2-positive breast cancer, compared...

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