25 October 2017 - Genentech announced today that the U.S. FDA has accepted the company's supplemental biologics license application for Avastin (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin alone, for the front-line treatment of women with advanced ovarian cancer.

“About 8% 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, M.D., chief medical officer and head of Global Product Development. “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 Avastin, in combination with carboplatin and paclitaxel, followed by Avastin 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 pivotal Phase III GOG-0218 trial. In newly diagnosed advanced ovarian cancer, the first treatment a woman receives after surgery is known as front-line treatment. The FDA is expected to make a decision on approval by 25 June 2018.

Read Genentech press release