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FDA Grants Genentech’s Avastin Priority Review for Recurrent Platinum-Resistant Ovarian Cancer

Tue, 07/22/2014 - 8:13am

Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin® (bevacizumab) plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer.

“The majority of women with ovarian cancer will become resistant to platinum therapy and a quarter of women will have platinum-resistant disease at the time of a first recurrence. New treatment options are needed,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We look forward to working with the FDA to bring this potential option to women with this difficult-to-treat cancer as soon as possible.”

The designation of Priority Review status is granted to medicines that the FDA believes have the potential to provide “significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.” The sBLA for Avastin plus chemotherapy for recurrent platinum-resistant ovarian cancer is based on data from the Phase III AURELIA trial with an FDA action date of November 19, 2014. 

About the AURELIA Study
AURELIA is a company-sponsored, multicenter, randomized, open-label, Phase III 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 liposomal doxorubicin with or without Avastin). Study data showed: 
•    The study met its primary endpoint and showed that Avastin plus chemotherapy reduced the risk of disease worsening (progression-free survival, PFS) by 52 percent compared to chemotherapy alone (median PFS: 6.7 months vs. 3.4 months; Hazard Ratio (HR)=0.48, p<0.001). No statistically significant difference was seen in the secondary endpoint of overall survival (median OS: 16.6 months vs. 13.3 months; HR=0.85, p<0.174).

            o    Women in the Avastin plus paclitaxel arm (n=60) experienced a 54 percent reduction in the risk of their disease worsening (median PFS: 10.4 months vs. 3.9 months; HR=0.46, 95% CI 0.30-0.71) and a 35 percent reduction in the risk of death (median OS: 22.4 months vs. 13.2 months; HR=0.65, 95% CI 0.42-1.02).
•    The study showed women who received Avastin plus chemotherapy had a significantly higher rate of tumor shrinkage (objective response rate, ORR) compared to chemotherapy alone when evaluated by the RECIST criteria (27.3 percent vs. 11.8 percent, respectively; p=0.001).
•    Grade 3-5 adverse events occurring at a higher incidence (> 2 percent) in women receiving Avastin plus chemotherapy compared to women receiving chemotherapy alone were hypertension (high blood pressure; 7 percent vs. 1 percent), proteinuria (too much protein in the urine; 2 percent vs. 0 percent) and gastrointestinal perforations (a hole in the stomach or intestine; 2 percent vs. 0 percent).

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