Priority Review, sBLA Granted for Cervical Cancer Tx
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 persistent, recurrent or metastatic cervical cancer.
The sBLA submission for Avastin plus chemotherapy is based on data from the Phase 3 GOG-0240 trial. GOG-0240 assessed the efficacy and safety profile of Avastin plus chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) in women with persistent, recurrent, or metastatic cervical cancer. The study data included 452 women and met its primary endpoint of improving overall survival (OS) with a statistically significant 29% reduction in the risk of death for women who received Avastin plus chemotherapy compared to those who received chemotherapy alone (median OS: 17 months vs. 13.3 months; Hazard Ration (HR)=0.71, P=0.004). Women in the Avastin plus chemotherapy treatment arm also lived longer without disease worsening (progression free survival, PFS) compared to those who received chemotherapy alone (median PFS: 8.2 months vs. 5.9 months; HR=0.67, P=0.002).
Avastin, an angiogenesis inhibitor, is already indicated for the treatment of metastatic colorectal carcinoma, in combination with 5-FU-based chemotherapy; 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.
For more information call (800) 821-8590 or visit Avastin.com.