Drug for Treatment of Platinum Resistant Recurrent Ovarian Cancer Approved for Use in Europe

For the first time in more than 15 years the European Commission (EC) has approved a new therapeutic option for the most difficult to treat form of ovarian cancer.

Ovarian cancer causes more deaths than any other gynecologic cancer. It is the seventh most commonly diagnosed cancer in women worldwide, with an estimated 230,000 cases diagnosed around the world every year and there are approximately 150,000 deaths from the disease. In the European Union, there are an estimated 44,000 cases of ovarian cancer every year, and nearly 30,000 women will die from the disease.

The newly approved drug is bevacizumab, an antibody derived from Chinese hamster ovary cells combined with a mouse protein. It sold in the United States under the brand name Avastin and is manufactured by Genentech (San Francisco, CA, USA), a subsidiary of Roche (Basel, Switzerland).

Avastin works by blocking the action of vascular endothelial growth factor (VEGF). VEGF stimulates the growth of new blood vessels in the process known as angiogenesis. Avastin antibodies bind tightly to VEGF and inactivate it. As a result, new blood vessels are not formed, and cancer tumor growth is inhibited by lack of an adequate supply of blood. Treated tumors cannot get larger and may even shrink. Thus, Avastin does not work directly on the tumor, but prevents its growth by reducing its supply of blood.

The EC has now approved the use of Avastin in combination with the chemotherapeutic drugs paclitaxel, topotecan, or pegylated liposomal doxorubicin as a treatment for women with recurrent ovarian cancer that is resistant to platinum-containing chemotherapy. 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.

“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,” said Dr. Sandra Horning, chief medical officer and head of global product development at Roche. “Avastin is the first biologic medicine approved by the EU for women with this difficult to treat disease.”

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