publication date: Nov. 14, 2014

Avastin Combination Approved In Recurrent Ovarian Cancer

FDA approved Avastin in combination with chemotherapy for the treatment of women with platinum-resistant, recurrent ovarian cancer.

The new indication of Avastin is in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan chemotherapy for the treatment of 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 U.S. to treat six distinct tumor types.

The approval was based on results from the phase III AURELIA study that showed Avastin plus chemotherapy reduced the risk of disease worsening or death by 62 percent compared to women who received chemotherapy alone. The median progression-free survival was 6.8 months in the Avastin arm compared to 3.4 months in the control arm (HR=0.38; p<0.0001).

Overall survival was 16.6 months in the Avastin arm compared to 13.3 with chemotherapy alone (HR=0.89 [95% CI: 0.69, 1.14])

AURELIA is a multicenter, randomized, open-label study 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. Participants were randomized to one of six treatment arms (paclitaxel, topotecan or pegylated liposomal doxorubicin with or without Avastin). Avastin is sponsored by Genentech, a member of the Roche Group.

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