The U.S. Food and Drug Administration (FDA) has approved 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.
“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 (NOCC). “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 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 pivotal Phase III GOG-0218 trial.
Women who received bevacizumab in combination with chemotherapy, and continued use of bevacizumab 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 bevacizumab total).
Bevacizumab has boxed warnings for GI perforation, surgery and wound healing complications and haemorrhage.
Bevacizumab is now approved for ten distinct uses across six different types of cancer in the United States.
This indication represents bevacizumab's fourth gynecologic oncology indication in four years, including advanced cervical cancer and two different forms of ovarian cancer that recurred after platinum-based chemotherapy.
“Today’s approval is an important advance for women newly diagnosed with this type of ovarian cancer,” said Sandra Horning, M.D., Genentech chief medical officer and head of Global Product Development. “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.”