FDA to Review Genentech’s Avastin as Front-line Treatment for Advanced Ovarian Cancer

FDA to Review Genentech’s Avastin as Front-line Treatment for Advanced Ovarian Cancer
The U.S. Food and Drug Administration has accepted for review Genentech's supplemental Biologics License Application (sBLA) seeking the approval of Avastin (bevacizumab) in combination with chemotherapy, as a front-line treatment for women with advanced ovarian cancer. The FDA's decision is expected by June 25, 2018. Front-line treatment in ovarian cancer is the first treatment a woman receives after surgery. “About 80 percent of women with ovarian cancer are diagnosed in the advanced stages when the disease is difficult to treat and options are limited,” Sandra Horning, MD, chief medical officer and head of Global Product Development, said in a press release. “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.” The sBLA is based on data from the GOG-0218 Phase 3 clinical trial (NCT00262847), reported in 2011. The study included 1,873 women with previously untreated epithelial ovarian carcinoma, primary peritoneal, or fallopian tube carcinoma, whose tumors already had been surgically removed. Participants were randomly assigned chemotherapy alone (Paraplatin (carboplatin) plus Taxol (paclitaxel)), chemotherapy plus Avastin followed by placebo, or chemotherapy plus Avastin, followed by Avastin alone. Those in the last treatment group (Avastin alone) lived the longest without disease progression, the study found. Compared to participants receiving Avastin plus chemot
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