Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's 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. 

 “This regulatory application for Avastin is important because chemotherapy is the only approved treatment for women with metastatic, recurrent or persistent cervical cancer,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Treatment with Avastin plus chemotherapy may help women with these conditions live longer than chemotherapy alone, and we look forward to working with the FDA on potentially making this medicine available to patients.”

The designation of Priority Review status is granted to medicines that the FDA believes have the potential to provide “significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.” The sBLA for Avastin plus chemotherapy in persistent, recurrent or metastatic cervical cancer is based on data from the Phase III GOG-0240 trial with an FDA action date of October 24, 2014.

For more details, go to: http://www.gene.com/media/press-releases/14569/2014-07-14/fda-grants-genentechs-avastin-priority-r