FDA Approves Herceptin as HER2 Breast Cancer Treatment

Genentech received approval from the FDA for Herceptin, a treatment regimen containing doxorubicin, cyclophosphamide, and paclitaxel, for the adjuvant treatment of HER2-positive node-positive breast cancer. 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.

The approval was based on data from an interim joint analysis of more than 3,500 patients in two Phase III 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% in women with HER2-positive breast cancer, compared to those patients who received standard adjuvant therapy alone.

After 3.5 years in the study, 87% of women treated with Herceptin plus chemotherapy were disease free, compared to 71% of women treated with chemotherapy alone. A survival analysis conducted after an average of 24 months showed a 33% reduction in the risk of death, or a 49% improvement in overall survival.