Genentech (DNA) has received an additional regulatory approval for its breast-cancer drug Herceptin, allowing the medication to be given to a broader group of patients.
The drug can now be used, along with a regimen of doxorubicin, cyclophosphamide and paclitaxel chemotherapy, as a treatment of early-stage, localized lymph-node positive breast cancer in patients also classified as positive for the protein known as HER2.
The goal of the treatment would be to reduce the risk of cancer recurrence and the chance of having the cancer spread to other parts of the body. Herceptin is already approved for metastatic breast cancer.
The most recent FDA approval was based on data from analyses of more than 3,500 patients enrolled in two phase III clinical trials. The study showed that the addition of Herceptin to standard treatments lowered the possibility of breast cancer recurrence by 52%.
After three-and-a-half years, 87% of women in the study who were treated with the drug were disease-free, compared with 71% of those treated with chemo alone. A survival analysis after a median of two years found that use of the drug led to a 33% reduction in the risk of death.