Today, the U.S. Food and Drug Administration (FDA) approved bevacizumab (Avastin) in combination with chemotherapy (carboplatin and paclitaxel) followed by bevacizumab as a single agent for the treatment of women with advanced (stage III or IV) ovarian cancer following initial surgical resection.
“Today’s approval is an important advance for women newly diagnosed with this type of ovarian cancer,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development at Genentech. “We’re committed to advancing medicines in areas of unmet need and this FDA approval of bevacizumab plus chemotherapy gives women with advanced ovarian cancer a new treatment option that has been shown to significantly delay disease progression or death.”
“This approval represents an important milestone as the first medicine, other than chemotherapy, for women with advanced ovarian cancer after their initial surgery,” said Melissa Aucoin, Chief Executive Officer, National Ovarian Cancer Coalition.
The approval for bevacizumab in combination with carboplatin and paclitaxel followed by bevacizumab 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 phase III Gynecologic Oncology Group (GOG)-0218 trial.
Participants were randomly assigned to one of three treatment arms: chemotherapy alone (carboplatin and paclitaxel), bevacizumab (15 mg/kg) plus chemotherapy followed by placebo alone, or bevacizumab plus chemotherapy followed by bevacizumab alone for a total of up to 22 cycles. The primary endpoint of the study was investigator-assessed progression-free survival, and secondary endpoints included overall survival. The study was conducted by the GOG, and initial results were previously published in The New England Journal of Medicine.
Women who received bevacizumab in combination with chemotherapy, and continued use of bevacizumab alone, had a median progression-free survival of 18.2 months compared to 12.0 months in women who received chemotherapy alone (hazard ratio [HR] = 0.62, 95% confidence interval [CI] = 0.52–0.75; P < .0001). This progression-free survival benefit was achieved with a fixed-duration treatment (up to 22 cycles of bevacizumab total).
Bevacizumab has boxed warnings for gastrointestinal perforation, surgery and wound healing complications, and hemorrhage.
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