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FDA Accepts sBLA, Grants Priority Review

FDA Accepts sBLA, Grants Priority Review for Avastin in Ovarian Cancer

This article was originally posted by Monthly Prescribing Reference.

Genentech announced that the FDA has accepted its 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 sBLA for Avastin plus chemotherapy is based on data from the Phase 3 AURELIA trial. 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. Participants were randomized to one of six treatment arms (paclitaxel, topotecan or liposomal doxorubicin with or without Avastin).

The study met its primary endpoint and showed that Avastin plus chemotherapy reduced the risk of disease worsening (progression-free survival, PFS) by 52% compared to chemotherapy alone (median PFS: 6.7 months vs. 3.4 months; HR=0.48, P<0.001). Women in the Avastin plus paclitaxel arm (n=60) experienced a 54% 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).

Avastin, an angiogenesis inhibitor, is already indicated for the first or second line treatment of metastatic colorectal carcinoma, in combination with 5-FU-based chemotherapy; second-line treatment of metastatic colorectal cancer, in combination with fluoropyrimidine- irinotecan-, or fluoropyrimidine- oxaliptan-based chemotherapy, in patients who have progressed on a first-line Avastin-containing regimen; first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (NSCLC), in combination with carboplatin and paclitaxel; treatment of glioblastoma with progressive disease following prior therapy as a single agent; and in the treatment of metastatic renal cell carcinoma with interferon alfa. Avastin has also recently been granted priority review in the treatment of cervical cancer.