The FDA has accepted the supplemental Biologics License Application (sBLA) for bevacizumab in combination with chemotherapy (carboplatin and paclitaxel), followed by bevacizumab alone, for the front-line treatment of women with advanced ovarian cancer.
This sBLA is based on data from GOG-0218 trial (NCT00262847), a multi-center, 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 (HR=0.64; 95% CI 0.54 - 0.77, p<0.0001).