Roche has announced that it has submitted a marketing authorization application to the European Medicines Agency (EMEA) for the use of its cancer drug Avastin in previously untreated advanced (metastatic) breast cancer. The filing is based on Phase III trial data that show that the addition of Avastin to standard chemotherapy as a primary treatment for advanced breast cancer doubled the time women lived without their disease advancing, when compared with chemotherapy alone.
This is the first Phase III study to evaluate the drug in combination with chemotherapy for first-line treatment of metastatic breast cancer. This randomized, controlled, multicenter study enrolled 722 women with previously untreated metastatic breast cancer. The study was sponsored by the National Cancer Institute (NCI) of the NIH, and conducted by a network of researchers led by the Eastern Cooperative Oncology Group (ECOG). The patients were randomized to receive treatment with paclitaxel with or without Avastin. The drug was given at a dose of 10 mg/kg every two weeks until disease progression. The results showed that patients receiving Avastin plus paclitaxel had a median progression-free survival (PFS) of more than a year while patients receiving paclitaxel alone had a median PFS of approximately six months.