Genetech Wins FDA Approval For Herceptin For Breast Cancer

Genentech (DNA) announced that the FDA approved its Herceptin cancer treatment for an expanded use for adjuvant treatment of HER2-positive node-positive breast cancer. The studies showed a 52% reduction in the recurrence of breast cancer of some 3,500 patients in two Phase III studies and is the only targeted biologic therapy approved for use in adjuvant and metastatic HER2-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. After three-and-a-half years in the study, 87 percent of women treated with Herceptin plus chemotherapy were disease free, compared to 71 percent of women treated with chemotherapy alone. A survival analysis conducted after patients had been followed for a median of 24 months showed a 33 percent reduction in the risk of death (based on a hazard ratio of 0.67), which is equivalent to a 49 percent improvement in overall survival.DNA shares closed up 0.35% at $80.72 in regulartrading, but shares are up 0.9% at $81.45 in after-hours trading. DNA has a 52-week trading range of $75.58 to $100.20.Jon C. Ogg