Avastin Gets FDA Approval for New Use

Genentech announces FDA approval of Avastin plus chemotherapy for treatment of platinum resistant, recurrent ovarian cancer

(RxWiki News) The US Food and Drug Administration (FDA) has approved a new use for the cancer medication Avastin (bevacizumab), according to biotechnology company Genentech.

On Friday, Genentech announced that the FDA approved Avastin in combination with chemotherapy to treat women with platinum-resistant, recurrent ovarian cancer.

Platinum-resistant recurrence means that the ovarian cancer comes back within six months of completing a platinum-based chemotherapy regimen. According to Genentech, platinum-resistant ovarian cancer is the most difficult-to-treat form of the disease.

The approval of Avastin is based on results from the Phase III AURELIA study. Genentech reports that this study showed that women who received Avastin plus chemotherapy had a lower risk of the cancer worsening or death than those who received chemotherapy alone.

"Avastin plus chemotherapy is the first new treatment option for women with this difficult-to-treat type of ovarian cancer in more than 15 years," said Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech. "Risk of the disease worsening was reduced by 62 percent for women who received Avastin plus chemotherapy in the study, and a notable treatment effect was observed with paclitaxel, which may be important when choosing treatment."

In past clinical trials for different types of cancer, certain serious and sometimes deadly side effects occurred more often in people who received Avastin than in those who did not.

These side effects included fistula formation (the forming of an abnormal passage in the body), stroke, heart problems, kidney problems, blood clots and fertility issues in women.

In the recent AURELIA study, side effects of Avastin included high blood pressure and pain, redness or swelling of the hands or feet.

The new approved use of Avastin is in combination with chemotherapy involving paclitaxel, pegylated liposomal doxorubicin or topotecan to treat women with platinum-resistant, recurrent, epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received no more than two past chemotherapy regimens.

Avastin is now approved to treat six different types of cancer, which include colon, rectal, lung, kidney, cervical and ovarian cancers.

Review Date: 
November 14, 2014