FDA Approves New Treatment for Recurrent Ovarian Cancer

The FDA today approved a new indication for an oncology drug that significantly reduces ovarian cancer disease progression.

In combination with chemotherapy, Genentech’s bevacizumab (Avastin) was found to reduce the risk of the disease worsening or leading to death in women with ovarian cancer by 62%, compared with those who only 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 Genentech chief medical officer Sandra Horning, MD, in a press release. “Risk of the disease worsening was reduced by 62% 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."

Bevacizumab is now approved in the United States for the treatment of 6 distinct tumor types.

The drug’s approval was based on results from a multicenter, randomized, open-label, phase 3 study that enrolled 361 women with platinum-resistant, recurrent, epithelial ovarian, primary peritoneal, or fallopian tube cancer, who received no more than 2 chemotherapy regimens in the past. Participants were randomized to 6 treatment arms, which were treated with paclitaxel, topotecan, or pegylated liposomal doxorubicin with or without bevacizumab.

Participants in the bevacizumab plus chemotherapy group had a median progression-free survival of 6.8 months, compared with 3.4 months with chemotherapy alone. Median overall survival was 16.6 months in the bevacizumab group, compared with 13.3 months with chemotherapy alone.

The overall response rate in the bevacizumab group was 28%, compared with 13% in the chemotherapy group.

Adverse events attributed to bevacizumab included high blood pressure and pain, redness or swelling of the hands or feet.