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The Food and Drug Administration has approved the use of Avastin (bevacizumab) in combination with chemotherapy for the treatment of patients with platinum-resistant, recurrent, epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received no more than two prior chemotherapy regimens.

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The biologic antibody that binds to vascular endothelial growth factor (VEGF) to prevent tumor metastasis by inhibiting tumor blood supply is indicated for use with paclitaxel, pegylated liposomal doxorubicin, or topotecan chemotherapy.


Avastin, made by Genentech, was granted priority review for this indication and for persistent, recurrent, or metastatic cervical cancers earlier this year (OT 9/10/14 issue). And, the drug also has approved indications for the treatment of patients with metastatic colorectal cancer (OT 2/25/13 issue); and for the treatment of patients with first-line or previously untreated metastatic colorectal cancer (OT 3/25/04 issue).


The approval for the new indication was based on data from the multicenter, randomized, Phase III AURELIA study of 361 women with platinum-resistant, recurrent, epithelial ovarian, primary peritoneal, or fallopian tube cancer, who had received no more than two anticancer regimens prior to enrollment in the trial. Patients were randomized to one of six treatment arms (paclitaxel, topotecan, or pegylated liposomal doxorubicin with or without Avastin).


Median progression-free survival was 6.8 months for women receiving Avastin plus chemotherapy, compared with 3.4 months for women receiving chemotherapy alone.


Adverse events were consistent with those seen in previous trials of Avastin across tumor types for approved indications, but also included high blood pressure, pain, and redness or swelling of the hands or feet.