The EC has broadened the existing breast cancer label for Roche’s Avastin (bevacizumab) to include its use in combination with Xeloda (capecitabine) as first-line therapy against metastatic disease. The latest marketing approval in Europe coincides with an FDA advisory committee recommending withdrawing the existing U.S. approval of Avastin as combination therapy with paclitaxel in the first-line treatment for Her2-negative metastatic breast cancer.
The latest approval for the drug in Europe as combination therapy with Xeloda provides a new first-line treatment option in cases where taxanes or anthracycline-based chemotherapies aren’t appropriate. Clearance was based on data from the Phase III Ribbon study, which demonstrated that the Avastin-Xeloda combination significantly boosted progression free survival (PFS) compared with Xeloda treatment alone. Median PFS times were 8.6 months and 5.7 months, respectively. 35.4% of women receiving the combination therapy also experienced major tumor shrinkage, compared with 23.6% of women in the Xeloda treatment arm.
In contrast with FDA’s possible withdrawal of Avastin for the metastatic breast cancer indication, the European Medicines Agency has already confirmed it will uphold the existing European marketing approval for the Avastin/paclitaxel combination against metastatic breast cancer, following a recommendation made in March by its Committee for Medicinal Products for Human Use. However, the agency has withdrawn the combination of Avastin with docetaxel for the first-line treatment of metastatic breast cancer.
Avastin is currently approved in the U.S. and Europe for the treatment of advanced colorectal, breast, non-small-cell lung and kidney cancers, and in the U.S. and other territories for the treatment of glioblastoma. The drug represented Roche’s biggest selling pharmaceutical in 2010, achieving sales of CHF 6.4 billion (about $7.7 billion), up 9% on 2009.