The approval in the European Union (EU) was based on results of the Phase III Aurelia trial which included women with recurrent, platinum-resistant ovarian cancer who received either chemotherapy or Avastin in combination with chemotherapy.
The company said that the addition of Avastin to chemotherapy gave a clinically meaningful benefit, nearly doubling the median progression free survival (PFS) from 3.4 to 6.7 months.
Roche chief medical officer and head of Global Product Development Dr Sandra Horning said the European approval of Avastin for recurrent, platinum-resistant ovarian cancer is good news because the drug can help women live longer without their cancer progressing, which is an important treatment goal in advanced disease.
"Avastin is the first biologic medicine approved by the EU for women with this difficult to treat disease," Horning said.
The EU approval will allow the use of Avastin in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin to treat women with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
The treatment will be carried out in women who received no more than two prior chemotherapy regimens and who have not received prior therapy with Avastin or other VEGF inhibitors or VEGF receptor-targeted agents.
Aurelia is the fourth Phase III trial of Avastin in ovarian cancer to show that the addition of Avastin to chemotherapy significantly increased the time women with ovarian cancer lived without their disease worsening.
Image: The European approval of Roche’s Avastin was based on results of the Phase III Aurelia trial. Photo: courtesy of Baitong333/ freedigitalphotos.net.