Roche Gets EU Approval For Avastin In Ovarian Cancer

The European Commission has approved Roche’s Avastin (bevacizumab) in combination with chemotherapy for the treatment of women with recurrent, platinum-resistant ovarian cancer.

Avastin is an antibody that specifically targets and inhibits vascular endothelial growth factor (VEGF), an important driving force behind tumor growth. The EU approval allows Avastin to be used in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin chemotherapy in treatment-naïve patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

The approval was based on positive results from the randomized, open label, multicenter, two arm Phase III study showing that Avastin almost doubled the median progression free survival (PFS) in participants compared to chemotherapy alone. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive recommendation for Avastin’s approval last month.

Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development, 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.” Horning stated that the drug is the first biologic medicine to receive approval for marketing in the EU for women with recurrent, platinum-resistant ovarian cancer.

Ovarian cancer leads the numbers in mortality rate of all gynecological cancers. An estimated 230,000 cases are diagnosed every year in the world with around 150,000 related deaths every year worldwide. In the EU 44,000 are diagnosed every year with 30,000 women dying from the disease. More than 10,000 in the EU every year will have platinum-resistant ovarian cancer and their disease will worsen between one to six months after platinum-based chemotherapy. It is currently the most difficult form of ovarian cancer to treat.

Avastin was first approved in the U.S. for the treatment of colorectal cancer in 2004. It has since received approval in the EU and more than 60 countries as treatment for a range of advanced cancers including glioblastoma, non-small cell lung cancer (NSCLC), breast cancer, and kidney cancer.