Roche files with Herceptin for early-stage HER2 positive breast cancer in Europe

Swiss pharmaceutical and diagnostics major Roche has submitted a Marketing Authorization application to the European Medicines Agency (EMEA) for its Herceptin (trastuzumab) as adjuvant treatment for early-stage, post-surgery 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 returning, an outstanding 46%.

Herceptin, which is already approved by the EMEA and the US Food and Drug Administration as adjuvant treatment for advanced metastatic breast cancer, has been the subject of legal a wrangle in the UK, where a patient has not been allowed to be prescribed the drug for early-stage disease (see story this page). The drug recorded sales of 2.1 billion Swiss francs ($1.61 billion) in 2005 (Marketletter February 6).

HER2-positive breast cancer, which affects arbout 20%-30% of women with the disease, demands special and immediate attention because HER2-positive tumors are fast growing. Results from four large trials, with nearly 12,000 patients analyzed 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, says Roche.