Roche has made a formal application to the European Medicines Agency (EMEA) to enable the use of Herceptin (trastuzumab) as a viable treatment for advanced HER2-positive and hormone receptor-positive breast cancer.
The application follows the encouragement received from the international TAnDEM study which showed that the use of Herceptin enhances the median progression-free survival from 2.4 months to 4.8 months.
HER2-positive breast cancer affects almost 20 to 30 percent of women with breast cancer, and is a galloping form of the disease that demands immediate attention due to the tumors growing at a rapid rate with a greater chance of relapse.
Eduard Holdener, Global Head of Roche Pharma Development said, "The results from the TAnDEM study show once again that Herceptin should be the backbone for all HER2-positive breast cancer patients -- it consistently benefits patients regardless of whether it is given in the early- or advanced-stage settings, or whether it is in combination with chemotherapy, hormonal therapy, or as a single agent. This combination offers a new treatment regimen for patients who suffer from a particularly aggressive form of breast cancer, and we are pleased to have been able to progress this application so quickly."