European Commission clears Roche's Avastin for platinum-resistant recurrent ovarian cancer

Roche announced Wednesday that the European Commission approved the use of Avastin (bevacizumab) in combination with chemotherapy as a treatment for women with recurrent ovarian cancer that is resistant to platinum-containing chemotherapy. The company noted that the drug is the "first new treatment option for women in Europe in more than 15 years" for this form of ovarian cancer, with chief medical officer Sandra Horning adding that Avastin "is the first biologic medicine approved by the EU" in this indication.

The decision, which follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in June, was based on results from the Phase III AURELIA study. The trial included 361 women with recurrent, platinum-resistant ovarian cancer, with results showing that the addition of Avastin to chemotherapy gave a clinically meaningful benefit, nearly doubling the median progression-free survival from 3.4 months to 6.7 months.

Roche indicated that the approval will enable the use of Avastin in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin for the treatment of women with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer 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.

Avastin is approved in Europe as a front-line treatment for advanced ovarian cancer and is also authorised as a treatment for recurrent, platinum-sensitive ovarian cancer. Sales of the drug, which is also cleared in the EU to treat advanced stages of breast cancer, colorectal cancer, non-small-cell lung cancer and kidney cancer, reached nearly 6.3 billion Swiss francs ($6.9 billion) last year.

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