The FDA approval is based on results from the Phase III AURELIA trial that showed Avastin plus chemotherapy reduced the risk of disease worsening or death (progression-free survival) by 62% compared to women who received chemotherapy alone.
The multicenter, randomized, open-label, Phase III trial was conducted in 361 women with platinum-resistant, recurrent, epithelial ovarian, primary peritoneal, or fallopian tube cancer, who had received no more than two anticancer regimens prior to enrollment in the trial.
During the trial, patients were randomized to one of six treatment arms (paclitaxel, topotecan or pegylated liposomal doxorubicin with or without Avastin).
Genentech chief medical officer and head of Global Product Development Dr Sandra Horning said: "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.
"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."
The new indication of Avastin is in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan chemotherapy to treat women with platinum-resistant, recurrent, epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received no more than two prior chemotherapy regimens.
With this approval, Avastin is approved in the US for the treatment of six distinct tumor types.