Roche today announced that the US Food and Drug Administration (FDA) has approved Avastin? (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single agent, for the treatment of women with advanced (stage III or IV) ovarian cancer following initial surgical resection.
The approval for Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, for the treatment of women with stage III or stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection, is based on data from the pivotal phase III GOG-0218 trial. GOG-0218 (NCT00262847) is a multi-centre, randomised, double-blind, placebo-controlled, phase III study in 1,873 women with previously untreated stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube carcinoma who already had surgery to remove as much of the tumour as possible. Participants were randomied into one of three treatment arms: chemotherapy alone (carboplatin and paclitaxel), Avastin (15 mg/kg) plus chemotherapy followed by placebo alone, or Avastin plus chemotherapy followed by Avastin alone for a total of up to 22 cycles. The primary endpoint of the study was investigator-assessed PFS and secondary endpoints included overall survival (OS).
Women who received Avastin in combination with chemotherapy, and continued use of Avastin alone, had a median progression-free survival (PFS) of 18.2 months compared to 12.0 months in women who received chemotherapy alone (HR=0.62; 95% CI 0.52 - 0.75, p<0.0001). This PFS benefit was achieved with a fixed-duration treatment (up to 22 cycles of Avastin total).
Avastin has made anti-angiogenic therapy a fundamental pillar of cancer treatment today. Over 2.7 million patients have been treated with Avastin so far. A comprehensive clinical programme has investigated Avastin in over 50 tumour types.
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