Genentech, a unit of Swiss drug developer Roche, said Friday that the U.S. Food and Drug Administration extended a review of Avastin as an initial breast cancer treatment.
The agency will take an additional 90 days to review the application, citing the need to review new information submitted by the company.
The FDA anticipates making a decision on the drug by Dec. 17.
The FDA approved Avastin in 2008 for breast cancer patients based on a trial that showed it lengthened by more than five months the amount of time until the disease worsened. As a condition of approval, Roche was required to conduct follow-up studies to demonstrate further the benefits of adding Avastin to conventional chemotherapy.
Avastin is approved to treat several other types of cancer, including advanced colorectal, lung and kidney cancer.