Roche submits Avastin MAA to EMEA

Swiss drugmaker Roche says that it has submitted a Marketing Authorization Application to the European Medicines Agency (EMEA), requesting approval for the use of Avastin (bevacizumab) in previously-untreated metastatic breast cancer. The drug, which inhibits the function of the naturally-occurring vascular endothelial growth factor (VEGF), thereby preventing tumor angiogenesis, was developed by the Swiss major and its majority-owned US firm Genetech of the USA, as an innovative anticancer agent.

The application is based on the results of the Phase III E2100 trial, which demonstrated that Avastin, when added to standard chemotherapy, doubled the time to disease progression in comparison with those patients who received chemotherapy alone. Roche added that the product was safe and well-tolerated at a dosage of 10mg/kg, given once every two weeks.

Roche also said that it plans to file the drug in Europe for use in non-small cell lung cancer, as well as broadening its use in the treatment of colorectal cancer, which gained European approval early last year (Marketletter January 24, 2005). In addition, the firm reports that the drug was filed for an NSCLC indication with the US Food and Drug Administration earlier this year.