Genentech announced that the Food and Drug Administration (FDA) has approved Avastin (bevacizumab) in combination with carboplatin and paclitaxel, followed by Avastin monotherapy, for the treatment of women with advanced (stage III or IV) ovarian cancer after initial surgical resection.

The approval for treating stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer after initial surgical resection is supported by data from the Phase 3, multicenter, randomized, double-blind, placebo-controlled GOG-0218 trial. Women were randomized to 1 of 3 treatment arms: chemotherapy alone (carboplatin plus paclitaxel), Avastin plus chemotherapy followed by placebo alone, or Avastin plus chemotherapy followed by Avastin alone for up to 22 cycles. The primary endpoint was investigator-assessed progression-free survival (PFS); secondary endpoints included overall survival (OS).

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Study patients who received Avastin plus chemotherapy followed by Avastin alone, had a greater median PFS vs patients who received chemotherapy alone (18.2 months vs 12 months; hazard ratio [HR] 0.62, 95% CI, 0.52-0.75; P<.0001). This benefit was seen up to 22 total cycles of Avastin. Median OS was 43.8 months in the Avastin plus chemotherapy followed by Avastin alone arm vs 40.6 months in the chemotherapy alone arm (HR 0.89, 95% CI, 0.76, 1.05). 

Avastin, an angiogenesis inhibitor, is currently approved for 10 oncologic indications across 6 types of cancer in the US. It is supplied as 100mg and 400mg solution per vial for intravenous (IV) infusion after dilution. 

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