FDA Update: Bevacizumab Is Approved for Cervical Cancer
The FDA has approved bevacizumab (Avastin) for treating persistent, recurrent, or metastatic cervical cancer after studies show gains in overall survival.
The U.S. Food and Drug Administration (FDA) has announced its approval of the use of Avastin (bevacizumab) for the treatment of persistent, recurrent, or late-stage (metastatic) cervical cancer.
As explained in the FDA's announcement, cervical cancer commonly results from cell changes related to infection with human papillomaviruses (HPV). Although there are two licensed vaccines available to prevent many types of HPV that can cause cervical cancer, the National Cancer Institute estimates that 12,360 American women will be diagnosed with cervical cancer and 4,020 will die from the disease in 2014.
Bevacizumab works by interfering with the blood vessels that fuel the development of cancerous cells. The new indication for cervical cancer is approved for use in combination with chemotherapy drugs paclitaxel and cisplatin or in combination with paclitaxel and topotecan.
“Avastin is the first drug approved for patients with late-stage cervical cancer since the 2006 approval of topotecan with cisplatin,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “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, demonstrating the agency’s commitment to making promising therapies available to patients faster.”
The safety and effectiveness of bevacizumab for treating cervical cancer was evaluated in a clinical study involving 452 participants with persistent, recurrent, or late-stage disease. Participants were randomly assigned to receive paclitaxel and cisplatin with or without bevacizumab or paclitaxel and topotecan with or without bevacizumab. Overall survival increased to 16.8 months in participants who received chemotherapy plus bevacizumab, compared with 12.9 months in those receiving chemotherapy alone.
The most common adverse effects associated with bevacizumab use in patients with cervical cancer include fatigue, decreased appetite, hypertension, hyperglycemia, hypomagnesemia, urinary tract infection, headache, and decreased weight. Perforations of the GI tract and the development of enterovaginal fistula also were observed in patients treated with bevacizumab.
Avastin is marketed by Genentech (San Francisco), a member of the Roche Group.
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