The Food and Drug Administration approved a combination of Avastin (bevacizumab) plus the chemotherapy agents carboplatin and paclitaxel, followed by Avastin alone, for the treatment of patients with advanced ovarian cancer who have had surgical resection.
The Food and Drug Administration (FDA) approved a combination of Avastin (bevacizumab) plus the chemotherapy agents carboplatin and paclitaxel, followed by Avastin alone, for the treatment of patients with advanced ovarian cancer who have had surgical resection, according to Genentech, the manufacturer of the drug.
The regimen is approved for women who have stage 3 or stage 4 epithelial ovarian, fallopian tube or primary peritoneal cancer, and is based on data from the phase 3 GOG-0218 trial. In the trial, the women who received the combination had an average progression-free survival (PFS) of 18.2 months, compared to only 12 months in those who had chemotherapy alone.
The phase 3 study, which was published in the New England Journal of Medicine, included 1,873 women from multiple cancer institutions across the United States. Patients were randomized to one of three arms: chemotherapy alone; 15 mg/kg of Avastin plus chemotherapy, followed by placebo; or Avastin plus chemotherapy followed by Avastin alone for 22 cycles.
“Today’s approval is an important advance for women newly diagnosed with this type of ovarian cancer,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development in a press release. “We’re committed to advancing medicines in areas of unmet need and this FDA approval of Avastin plus chemotherapy gives women with advanced ovarian cancer a new treatment option that has been shown to significantly delay disease progression or death.”
Although most patients did not have serious side effects, some did. Potential serious side effects include: abnormal passage in the body, severe high blood pressure, kidney problems, infusion reactions, severe stroke or heart problems and nervous system or vision problems.
More common side effects include: high blood pressure, high protein in urine, nosebleeds, rectal bleeding, back pain, headache, taste change, dry skin, skin inflammation, nasal inflammation and watery eyes.
Now women who underwent surgery for their ovarian cancer treatment will have an option other than chemotherapy — a huge step in the right direction, according to Melissa Aucoin, CEO of the National Ovarian Cancer Coalition.
“This approval represents an important milestone as the first medicine, other than chemotherapy, for women with advanced ovarian cancer after their initial surgery,” she said in a release.