Avastin filed for broader breast cancer label in Europe for use in combination with standard chemotherapies
Roche announced that they have filed to extend the current European label of Avastin (bevacizumab) in patients with metastatic breast cancer to allow its use in combination with a broader range of standard chemotherapies. Avastin is currently licensed in the EU as first-line treatment for patients with metastatic breast cancer in combination with paclitaxel or docetaxel.
The new filing is supported by data from the double-blind, phase III RIBBON 1 study, the first phase III study to show Avastin’s benefit when combined with Xeloda (capecitabine) or anthracycline-based chemotherapies in this patient population as well as confirming the benefits of Avastin when combined with taxane-based chemotherapies. Avastin used at its standard dose (15 mg/q3w) was shown to increase the time women with breast cancer lived without their disease advancing (known as progression-free survival) compared to chemotherapy alone.
Patients receiving Avastin plus taxane or anthracycline-based chemotherapies had a 55 percent increase in the chance of being alive without disease progression compared to those who received the chemotherapies alone (hazard ratio=0.64; p<0.0001). Patients receiving Avastin plus Xeloda had a 45 percent increase in the chance of being alive without disease progression compared to those who received the chemotherapy alone (hazard ratio=0.69; p=0.0002).
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