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FDA grants priority review for Avastin for treatment of platinum-resistant ovarian cancer

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The FDA has granted priority review status to bevacizumab plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer.

The priority review for bevacizumab (Avastin, Genentech) plus chemotherapy was based on initial results of the phase 3 AURELIA trial, a multicenter, randomized open-label study.

Sandra Horning

“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,” Sandra Horning, MD, chief medical officer and head of global product development for Genentech, said in a company press release. “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 study included 361 women with platinum-resistant recurrent epithelial ovarian, primary peritoneal or fallopian tube cancer who had received no more than two anticancer regimens before enrollment in the trial.

Patients were randomly assigned to one of six treatments: paclitaxel, topotecan or liposomal doxorubicin with or without bevacizumab.

The study met its primary endpoint and showed that bevacizumab plus chemotherapy reduced PFS by 52% vs. chemotherapy alone (median PFS: 6.7 months vs. 3.4 months; HR=0.48; P<.001).

No statistically significant difference was seen in the secondary endpoint of OS (median OS: 16.6 months vs. 13.3 months; HR=0.85; P<.174).

Patients in the bevacizumab plus paclitaxel arm (n=60) experienced a 54% reduction in PFS risk (median PFS: 10.4 months vs. 3.9 months; HR=0.46, 95% CI 0.3-0.71) and a 35% reduction in mortality risk (median OS: 22.4 months vs. 13.2 months; HR=0.65, 95% CI 0.42-1.02).

According to study results, patients who received bevacizumab plus chemotherapy exhibited a significantly higher rate of tumor shrinkage (objective response rate=27.3%) compared with chemotherapy alone (ORR=11.8%) when evaluated by the RECIST criteria (P=.001).

Grade 3 to grade 5 adverse events that occurred at a higher incidence (>2%) among patients receiving bevacizumab plus chemotherapy vs. chemotherapy alone included hypertension, proteinuria and gastrointestinal perforations.