Genentech has announced that the Food and Drug Administration (FDA) has approved Avastin (bevacizumab) in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of women with persistent, recurrent, or metastatic cervical cancer. It is the first drug approved for patients with late-stage cervical cancer since the approval of topotecan with cisplatin in 2006.
The approval is based on the results of the GOG-0240 clinical trial assessing the safety and efficacy of Avastin in 452 patients with persistent, recurrent, or metastatic cervical cancer. The study met its primary endpoint of improving overall survival (OS) with a statistically significant 26% reduction in mortality risk for women receiving Avastin plus chemotherapy vs. chemotherapy alone median (OS: 16.8 months vs. 12.9 months; HR=0.74, P=0.0132). Women receiving Avastin plus chemotherapy also had a significantly higher rate of tumor shrinkage vs. chemotherapy alone (45%; 95% CI: 39%–52% vs. 34%; 95% CI: 28%–40%).
The FDA accepted the supplemental Biologics License Application (sBLA) for Avastin and granted it Priority Review in July 2014. 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.
For more information visit Genentech-Access.com.