EU approves Avastin + chemotherapy for recurrent Ovarian Cancer - Roche
Roche announced that the European Commission (EU) approved the use of Avastin (bevacizumab) in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin chemotherapy as a treatment for women with recurrent Ovarian Cancer that is resistant to platinum-containing chemotherapy.
The EU approval was based on results of the phase III AURELIA study which involved women with recurrent, platinum-resistant Ovarian Cancer who received either chemotherapy or Avastin in combination with chemotherapy. Results showed that the addition of Avastin to chemotherapy gave a clinically meaningful benefit, nearly doubling the median progression free survival (PFS) from 3.4 months to 6.7 months (HR=0.38, p<0.0001).>
In 2011, Avastin was approved in the EU as a front-line treatment for advanced Ovarian Cancer based on the pivotal GOG 0128 and ICON7 phase III studies. In 2012, Avastin was approved in the EU as a treatment for recurrent, platinum-sensitive Ovarian Cancer based on the results of the pivotal phase III OCEANS study.