Roche's Avastin Given Green Light For Ovarian Cancer By FDA

Women with platinum-resistant recurrent ovarian cancer have another treatment option available in the form of Avastin plus chemotherapy, Roche announced earlier this week following the combination’s approval from the U.S. Food and Drug Administration (FDA).

Avastin is an antibody that specifically inhibits vascular endothelial growth factor (VEGF) to stop tumors from growing and spreading in the body. The approval licenses Avastin for its sixth indication in the U.S. as treatment in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan chemotherapy for women with platinum-resistant, recurrent, epithelial ovarian, fallopian tube, or primary peritoneal cancer, and who underwent a maximum of two prior chemotherapy regimens.

The drug has received earlier approval in the EU as the first new treatment in 15 years for platinum-resistant ovarian cancer, the most difficult to treat form of ovarian disease that afflicts more than 10,000 women per year in the territory. A week later, Avastin plus chemotherapy was awarded FDA approval for the treatment of advanced cervical cancer.

The FDA approval was supported by positive results from the Phase 3 AURELIA study, which showed that the Avastin plus chemotherapy combination treatment cut the risk of disease progression or death by 62 percent compared to those who were treated with chemotherapy alone. The combo cancer therapy also achieved a median progression-free survival (PFS) of 6.8 months compared to 3.4 months on chemotherapy alone.

Sandra Horning, CMO and head of Global Product Development at Roche, said, “Avastin plus chemotherapy is the first new treatment option for women with this difficult-to-treat type of ovarian cancer in more than 15 years. Risk of the disease worsening was reduced by 62 percent for women who received Avastin plus chemotherapy in the study, and a notable treatment effect was observed with paclitaxel, which may be important when choosing treatment.”

The new approval will help Avastin maintain its spot as Roche’s top-performing drug, which, according to Reuters, had total sales of $6.53 billion in 2013 alone.