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FDA approves bevacizumab for advanced ovarian cancer


 

The Food and Drug Administration has approved bevacizumab (Avastin) for treating stage III or IV ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection, first in combination with chemotherapy (carboplatin and paclitaxel), then as monotherapy.

The approval was based on an improvement in progression-free survival (PFS) in the phase 3, three-arm GOG-0218 trial, evaluating the addition of bevacizumab to carboplatin and paclitaxel for patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection, the FDA said in a press statement.

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The study included 1,873 women with previously untreated disease randomized to receive either chemotherapy alone, chemotherapy plus bevacizumab followed by just placebo, or chemotherapy plus bevacizumab followed by bevacizumab alone. PFS was 18.2 months in the group that received bevacizumab plus chemotherapy then bevacizumab alone versus 12.0 months in the group that received only chemotherapy (hazard ratio, 0.62; 95% confidence interval, 0.52-0.75; P less than .0001).

The most serious adverse events of bevacizumab included gastrointestinal perforation, wounds that don’t heal, and serious bleeding. Other possible adverse events included kidney problems, fistula, severe high blood pressure, severe stroke or heart problems, and problems of the nervous system and vision. Less serious events included headache, nosebleeds, rectal bleeding, and dry skin.

The recommended bevacizumab dose for stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection is 15 mg/kg every 3 weeks with carboplatin and paclitaxel for up to 6 cycles, followed by 15 mg/kg every 3 weeks as a single agent, for a total of up to 22 cycles, the FDA said.

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