FDA OKs Roche's Avastin Plus Chemo In Cervical Cancer

The U.S. Food and Drug Administration (FDA) has approved Roche’s Avastin (bevacizumab) plus chemotherapy for the treatment of women with persistent, recurrent, or metastatic cervical cancer.

Avastin is an antibody that specifically targets and inhibits vascular endothelial growth factor (VEGF), a known key factor for driving tumor growth. First approved for colorectal cancer in 2004, the new indication makes the drug the first biologic to be approved with chemotherapy drugs paclitaxel and cisplatin or paclitaxel and topotecan for advanced cervical cancer.

“Avastin is the first drug approved for patients with late-stage cervical cancer since the 2006 approval of topotecan with cisplatin. It is also the first biologic agent approved for patients with late-stage cervical cancer and was approved in less than four months under the FDA’s priority review program,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

The approval was supported by positive results from a clinical study demonstrating Avastin’s safety and effectiveness in 452 patients with persistent, recurrent, or late-stage disease. Those who received Avastin with chemotherapy achieved a significant increase in overall survival than those who received chemotherapy alone.

Sandra Horning, CMO and Head of Global Product Development at Roche, said, “With this approval, women with advanced cervical cancer now have the option of Avastin plus chemotherapy to help them live longer than with chemotherapy alone. Cervical cancer is most commonly diagnosed in women between the ages of 35 and 44, and until today, chemotherapy was the only approved treatment option for women whose cancer recurred, persisted, or spread.”

Cervical cancer is usually due to human papillomaviruses (HPV), which causes cells to become cancerous. Though there are vaccines available to prevent many types of HPV that can cause cancer of the cervix, an estimated 12,360 women in the U.S. will be diagnosed in 2014. For these 12,000, an estimated 4,020 will die from the disease, according to the National Cancer Institute.

Avastin is currently marketed by Roche Group member, Genentech.