The gynecological cancer community is celebrating another milestone in the treatment of cervical cancer. Ahead of schedule, the Food and Drug Administration approved Avastin (bevacizumab) for women with recurrent, persistent or metastatic cervical cancer (read more). Avastin is the first biological drug to be approved for advanced cervical cancer, a mere four months after it was accepted in the FDA's priority review program. Drugs that show the potential to improve efficacy or safety over currently available treatments can be accepted into the priority review program, which expedites the agency's review from nine months to six months. (You can read more on priority review in "A Primer on How Faster Approval Works.") This latest approval was based on a study of 452 participants who were randomized to receive two different chemotherapy regimens with or without Avastin. The addition of Avastin improved overall survival from 12.9 months to 16.8 months, regardless of chemotherapy regimen. The full results were published in a recent issue of the New England Journal of Medicine, which you can access here. Researchers noted in their study results that patients with advanced cervical cancer usually do not have sustained responses to chemotherapy, the standard of care for this disease. Given the aggressive nature of advanced cervical cancer, an improvement of nearly four months is considered meaningful. Some trial participants treated with Avastin, which works by disrupting the blood supply to tumors, experienced hypertension, fatigue and decreased appetite. Rare but severe occurrences of gastrointestinal perforations and fistulas were reported with the treatment.
