FDA Approves Bevacizumab to Treat Patients with Persistent, Recurrent or Metastatic Cervical Cancer
The first biologic agent approved for patients with late-stage cervical cancer
The USA Food and Drug Administration (FDA) approved on 14 August 2014 a new use for bevacizumab (Avastin) to treat patients with persistent, recurrent or metastatic cervical cancer.
Although there are two licensed vaccines available to prevent many types of human papillomaviruses (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 is antiangiogenic agent. 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 Dr Richard Pazdur, 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 FDA reviewed bevacizumab for treatment of patients with cervical cancer under its priority review programme because the drug demonstrated the potential to be a significant improvement in safety or effectiveness over available therapy in the treatment of a serious condition. Priority review provides an expedited review of a drug’s application.
Safety and effectiveness
The safety and effectiveness of bevacizumab for treatment of patients with 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. Results showed an increase in overall survival to 16.8 months in participants who received chemotherapy in combination with bevacizumab as compared to 12.9 months for those receiving chemotherapy alone.
The most common side effects associated with use of bevacizumab in patients with cervical cancer include fatigue, decreased appetite, hypertension, hyperglycaemia, hypomagnesaemia, urinary tract infection, headache and decreased weight. Perforations of the gastrointestinal tract and enterovaginal fistula were also observed in bevacizumab-treated patients.
Avastin is marketed by South San Francisco, California-based Genentech, a member of the Roche Group.