FDA approves angiogenesis inhibitor for late-stage and aggressive cervical cancer

Avastin (bevacizumab) has been approved to treat patients with persistent, recurrent, or metastatic cervical cancer by the US Food and Drug Administration (FDA). The drug is a vascular endothelial growth factor-specific angiogenesis inhibitor with previous indications in metastatic colorectal cancer, advanced nonsquamous non-small cell lung cancer, metastatic kidney cancer, and glioblastoma.

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This is the first drug to receive FDA approval for metastatic cervical cancer treatment since the 2006 approval of topotecan combined with cisplatin.

Due to the drug’s potential for significantly improved safety or effectiveness compared with standard therapies, Avastin received priority review and  approval after less than 4 months of review.

Its safety and effectiveness were evaluated through a clinical study of 452 patients who had persistent, recurrent, or metastatic cervical cancer. Each participant was randomly assigned to receive either paclitaxel and topotecan with or without Avastin or paclitaxel and cisplatin with or without Avastin. Overall survival increased to 16.8 months in those who received chemotherapy plus Avastin, compared with 12.9 months in women who received chemotherapy alone.

Side effects associated with use Avastin in cervical cancer patients included decreased weight, decreased magnesium in the blood, hypertension, hyperglycemia, hypomagnesemia, headache, fatigue, decreased appetite, and urinary tract infection. Enterovaginal fistulas and gastrointestinal tract perforations were also seen in the participants treated with the drug.