The European Commission has given approval to Roche to use Avastin (bevacizumab) in combination with paclitaxel, topotecan or pegylated liposomal doxorubicin chemotherapy to treat women with recurrent ovarian cancer, which is resistant to platinum-containing chemotherapy.
The approval has been given based on results of the Phase III Aurelia study, which included women with recurrent, platinum-resistant ovarian cancer who received either chemotherapy or Avastin in combination with chemotherapy.
According to the company, Phase III Aurelia study results demonstrated that the addition of Avastin to chemotherapy nearly doubled the median progression free survival (PFS) from 3.4 months to 6.7 months.
Roche chief medical officer and global product development head Dr Sandra Horning said: "European approval of Avastin for recurrent, platinum-resistant ovarian cancer is good news because Avastin 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."
Avastin was approved as a front-line treatment for advanced ovarian cancer in the EU in 2011, following the pivotal GOG 0128 and ICON7 Phase III studies.
The results of the pivotal Phase III OCEANS study further allowed it as the approved treatment for recurrent, platinum-sensitive ovarian cancer in the EU in 2012.
Image: Intermediate magnification micrograph of a low malignant potential (LMP) mucinous ovarian tumour. H&E stain. Photo: courtesy of Nephron.