Roche Files Herceptin for Early-Stage HER2-Positive Breast Cancer With European Authorities

21-Feb-2006

Roche announced the submission of a Marketing Authorisation application 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 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.

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.

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