Genentech, a member of the Roche Group, 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 recurrent platinum-resistant ovarian cancer.
“The majority of women with ovarian cancer will become resistant to platinum therapy and a quarter of women will have platinum-resistant disease at the time of a first recurrence. New treatment options are needed,” said Sandra Horning, chief medical officer and head of Global Product Development. “We look forward to working with the FDA to bring this potential option to women with this difficult-to-treat cancer as soon as possible.”
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 for recurrent platinum-resistant ovarian cancer is based on data from the Phase 3 AURELIA trial with an FDA action date of November 19, 2014.
Date: July 21, 2014