Roche submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for Herceptin (trastuzumab) as adjuvant treatment for early-stage HER2-positive breast cancer. The application is based on data from the international HERA (HERceptin Adjuvant) study which showed that Herceptin following standard chemotherapy significantly reduces the risk of cancer coming back, by an outstanding 46%.

HER2-positive breast cancer, which affects approximately 20 - 30% of women with breast cancer, demands special and immediate attention because HER2-positive tumours are fast growing. Results from four large trials, with nearly 12,000 patients analysed from around the globe, provide consistent evidence that Herceptin reduces the risk of cancer coming back by about half, providing the best chance of long-term survival to women with this aggressive form of early-stage breast cancer, stated a company release.

"The outstanding benefits we have seen from Herceptin as post-surgical therapy for early-stage breast cancer underpin the importance of securing patient access to this drug as quickly as possible," commented Ed Holdener, Head of Roche's Global Pharma Development.

Genentech similarly filed a supplemental Biologic License Application (sBLA) for the use of Herceptin in early-stage HER2-positive breast cancer with the US Food and Drug Administration (FDA) just two days before the European filing. The application is based on data from a combined interim analysis of two large US trials, and Genentech has requested a priority review designation.

Eight to nine percent of women will develop breast cancer during their lifetime, making it one of the most common types of cancer in women.6 Each year more than one million new cases of breast cancer are diagnosed worldwide, with a death rate of nearly 400,000 people per year.

In HER2-positive breast cancer, increased quantities of the HER2 protein are present on the surface of the tumour cells. This is known as 'HER2 positivity.' High levels of HER2 are present in a particularly aggressive form of the disease which responds poorly to chemotherapy. Research shows that HER2-positivity affects approximately 20-30% of women with breast cancer.