The Food and Drug Administration (FDA) has granted Priority Review status for the cancer drug Avastin (bevacizumab) plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer. Avastin is already approved to treat specific types of colorectal, lung, kidney, and brain cancers. Avastin was also granted priority review for the treatment of cervical cancer.
The Priority Review status is based on data from the Phase 3 AURELIA trial, a multicenter, randomized, open-label study in 361 women with platinum-resistant recurrent epithelial ovarian, primary peritoneal or fallopian tube cancer who have received no more than two anticancer regimens prior to enrollment. Participants were randomized to one of six treatment arms including one group with Avastin alone, five combining the drug with other treatments, and one group that was not treated with Avastin.
Data showed that Avastin plus chemotherapy reduced the risk of disease worsening (progression-free survival) by 52 percent compared to chemotherapy alone – 6.7 months compared to 3.4 months.
An estimated 21,980 new cases of ovarian cancer will be diagnosed in 2014, and 14,270 will die from the disease in the United States, according to the American Cancer Society. While it is only the eleventh most common cancer among women, ovarian cancer is the fifth leading cause of cancer-related deaths in women.
What causes women to develop ovarian cancer is hard to pin down but researchers say that there are risk factors. Those include advanced age, obesity, family history, exposure to fertility drugs, long-term use of estrogen (without progesterone), a history of certain medical conditions, smoking and alcohol use, and high-fat diets.
Another risk factor identified by Cancer.org is the use of talcum powder applied directly to the genital area or on sanitary napkins. Recently, a woman won a lawsuit against Johnson & Johnson claiming regular use of the company’s Shower to Shower talcum powder caused her to develop ovarian cancer. The jury agreed that the consumer health care giant knew of the potential risks and should have warned consumers on the product’s label.