Avastin filed for broader breast cancer label in Europe for use in combination with standard chemotherapies

30-Nov-2009 - Switzerland

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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).

https://www.bionity.com/en/news/110090/avastin-filed-for-broader-breast-cancer-label-in-europe-for-use-in-combination-with-standard-chemotherapies.html