On October 25, Genentech announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) for bevacizumab (Avastin) in combination with chemotherapy (carboplatin and paclitaxel), followed by bevacizumab alone, for the front-line treatment of women with advanced ovarian cancer. The FDA is expected to make a decision on approval by June 25, 2018.
“About 80% of women with ovarian cancer are diagnosed in the advanced stages, when the disease is difficult to treat and options are limited,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development at Genentech. “We are committed to working closely with the FDA to bring this potential new treatment option to women with newly diagnosed advanced ovarian cancer as soon as possible.”
This sBLA for bevacizumab, in combination with carboplatin and paclitaxel, followed by bevacizumab as a single agent, for the front-line treatment of people with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer, is based on data from the phase III GOG-0218 trial.
More About the GOG-0218 Study
GOG-0218 is a multicenter, randomized, double-blind, placebo-controlled phase III study in 1,873 women with previously untreated advanced epithelial ovarian, primary peritoneal, or fallopian tube carcinoma who already had surgery to remove as much of the tumor as possible. Participants were randomized into one of three treatment arms: chemotherapy alone (carboplatin and paclitaxel), bevacizumab (15 mg/kg) plus chemotherapy followed by placebo alone, or bevacizumab plus chemotherapy followed by bevacizumab alone.
Women who received bevacizumab in combination with chemotherapy, and continued use of bevacizumab alone for a total duration of 22 cycles, had a median progression-free survival of 18.2 months compared to 12.0 months in women who received chemotherapy alone (hazard ratio = 0.64; 95% confidence interval = 0.54–0.77, P < .0001). Secondary endpoints of the study included overall survival and objective response rate. Adverse events were consistent with those seen in previous trials of bevacizumab across tumor types for approved indications. The study was conducted by the Gynecologic Oncology Group, and their initial results were previously published in The New England Journal of Medicine.
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