FDA Approves Bevacizumab for Aggressive and Late-Stage Cervical Cancer

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The U.S. Food and Drug Administration (FDA) has approved the antiangiogenic agent bevacizumab (Avastin) for the treatment of persistent, recurrent, or metastatic cervical cancer. The new indication is approved for use in combination with paclitaxel and cisplatin or paclitaxel and topotecan. The FDA reviewed bevacizumab for the treatment of patients with cervical cancer under its priority review program.

“[Bevacizumab] 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 4 months under the FDA’s priority review program, demonstrating the agency’s commitment to making promising therapies available to patients faster.”

Clinical Trial Results

The approval was based on the results of an international, randomized trial enrolling 452 patients with persistent, recurrent, or metastatic disease. Patients were randomly assigned to receive paclitaxel and cisplatin with or without bevacizumab or paclitaxel and topotecan with or without bevacizumab. Treatment continued until disease progression, unacceptable toxicity, and/or withdrawal of consent.

Results demonstrated a statistically significant improvement in overall survival in patients who received bevacizumab and chemotherapy vs chemotherapy alone (hazard ratio [HR] = 0.74, 95% confidence interval [CI] = 0.58–0.94, P = .013, log-rank test). The median overall survival of patients receiving bevacizumab and chemotherapy was 16.8 months (95% CI = 14.1–19) vs 12.9 months (95% CI = 10.9–15) 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, hyperglycemia, hypomagnesemia, urinary tract infection, headache, and decreased weight.

Gastrointestinal perforations (3.2%) and gastrointestinal-vaginal fistulae (8.2%) were also observed in bevacizumab-treated patients, all of whom had prior pelvic radiation. Other grade 3 or greater adverse reactions that were more common in patients receiving chemotherapy plus bevacizumab included venous thromboembolic events, hemorrhage, hypertension, proteinuria, and wound-healing complications. ■




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