Pharmaceutical Industry discussion, review, analysis, news and information.

Roche has applied for marketing authorisation to the European Medicines Agency (EMEA) for Herceptin (trastuzumab) as treatment for advanced HER2-positive and hormone receptor-positive breast cancer. This application follows the release of results from an extensive trial, which demonstrated that Herceptin hormonal therapy doubled patients' median progression-free survival from 2. 4 months to 4.8 months.

“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,” said Eduard Holdener, Global Head of Roche Pharma Development. “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.”

See Roche's press release for more details of the TAnDEM trial, results of which were presented during the recently concluded European Society for Medical Oncology (ESMO) Congress.