Setback for Genentech

The FDA has denied Genentech's request to fast-track the application for its age-related macular degeneration (AMD) agent, Lucentis (ranibizumab). In response, Genentech announced it plans to file a complete Biologics License Application (BLA) for Lucentis for the treatment of neovascular AMD in December 2005, in a bid to speed up the process. Although the FDA rejected Genentech's request for fast-track designation, this should not affect the timing for BLA submission or the potential to obtain priority review.