FDA APPROVES HERCEPTIN® FOR THE ADJUVANT TREATMENT OF

FDA APPROVES HERCEPTIN® FOR THE ADJUVANT TREATMENT OF HER2-POSITIVE NODE-POSITIVE BREAST CANCERGenentech, Inc. announced today that the U.S. Food and Drug


Administration (FDA) approved Herceptin® (Trastuzumab) for the adjuvant treatment of HER2-positive node-positive breast cancer, as part of a treatment regimen containing doxorubicin, cyclophosphamide, and paclitaxel. 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 percent in women with HER2-positive breast cancer, compared to those patients who received standard adjuvant therapy alone.

Adjuvant therapy is given to women with early-stage (localized) breast cancer who have had initial treatment -- surgery with or without radiation therapy -- with the goal of reducing the risk of cancer recurrence and/or the occurrence of metastatic disease.