title: Lessons from the other side of the Atlantic.
abstract: In the United States, bevacizumab was approved for use in combination with paclitaxel for the treatment of metastatic breast cancer on the basis of a single trial showing a beneficial impact on progression-free survival, a surrogate endpoint. The indication in breast cancer was withdrawn in 2011 when a new review of the data showed no increase in overall survival. In the European Union, bevacizumab was approved for use in combination with paclitaxel or docetaxel, again based on an improvement in progression-free survival. Following a review of clinical trials using this same endpoint, the indication for combination with paclitaxel was maintained while the indication for combination with docetaxel was withdrawn in 2011. Furthermore, bevacizumab was approved for use in combination with capecitabine on the basis of progression-free survival data.
mesh_terms: D020533:Angiogenesis Inhibitors / Q000009:adverse effects*; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects*; D000068258:Bevacizumab; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D018572:Disease-Free Survival; D004345:Drug Industry; D005260:Female; D006801:Humans; D040541:Marketing
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab