FDA Approves Avastin in Combination with Chemotherapy as Treatment for Advanced Ovarian Cancers

FDA Approves Avastin in Combination with Chemotherapy as Treatment for Advanced Ovarian Cancers
The U.S. Food and Drug Administration (FDA) has approved the use of Avastin (bevacizumab) in combination with standard chemotherapy, followed by Avastin alone, as a front-line treatment for advanced ovarian cancers. This label extension is for women who have already undergone surgery and represents Avastin’s fourth indication as a treatment for gynecologic cancers. These include the treatment of advanced cervical cancer and two different forms of recurrent, platinum-resistant ovarian cancer. “This approval represents an important milestone as the first medicine, other than chemotherapy, for women with advanced ovarian cancer after their initial surgery,” Melissa Aucoin, interim CEO of the National Ovarian Cancer Coalition, said in a press release. “Ovarian cancer is the fifth leading cause of cancer-related deaths among women in the United States, and this approval underscores Genentech’s dedication to bringing new treatment options to women with gynecological cancers.” The decision was supported by clinical data from the GOG-0218 Phase 3 trial (NCT00262847). The study assessed the safety and efficacy of Avastin in 1,873 women with epithelial ovarian carcinoma, primary peritoneal, or fallopian tube carcinoma whose only treatment had been surgery to remove a tumor. Participants were randomized into three groups: one that received a chemotherapy regimen of Paraplatin (carboplatin) plus Taxol (paclitax
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