Genentech sBLA for Avastin in Ovarian Cancer

FDA has accepted for review a Genentech supplemental BLA for Avastin (bevacizumab) for its use in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin alone, for the front-line treatment of women with advanced ovarian cancer. The agency has set a user fee review action target date of 6/25/2018.

The submission is based on data from the pivotal Phase 3 GOG-0218 trial involving 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. “Women who received Avastin in combination with chemotherapy, and continued use of Avastin alone for a total duration of 22 cycles, had a median progression-free survival (PFS) of 18.2 months compared to 12 months in women who received chemotherapy alone,” the company says.