The FDA designates Genentech's (RHHBY +1.1%) sBLA for Avastin (bevacizumab) plus chemotherapy as a treatment for persistent, recurrent or metastatic cervical cancer for priority review. The agency's elevated review process is granted to medicines it believes have the potential to provide significant improvements in safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications.
Genentech's sBLA is based on a National Cancer Institute-sponsored 452-patient Phase 3 study that assessed the safety and efficacy of Avastin plus chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) in women with persistent, recurrent or metastatic cervical cancer.
Median overall survival (OS) improved to 17.0 months from 13.3 months compared to chemo alone. Median progression-free survival improved to 8.2 months from 5.9 months compared to chemo alone.