FDA fast track for Cell Genesys' GVAX

The US Food and Drug Administration (FDA) has granted fast-track designation for Cell Genesys' GVAX immunotherapy, the company's lead product candidate for the treatment of advanced prostate cancer. Fast-track designation, which was mandated by the FDA Modernization Act of 1997, can potentially facilitate development and expedite the review of Biologics License Applications.

GVAX is currently being studied in two Phase III clinical trials expected to enroll approximately 1,200 patients with metastatic hormone-refractory prostate cancer, comprising one of the largest Phase III programs ever conducted in men with advanced prostate cancer, the company says.

The first trial (VITAL-1) is enrolling chemotherapy naive, asymptomatic patients without cancer-related pain and will compare GVAX therapy to Taxotere (docetaxel) chemotherapy plus prednisone. The second (VITAL-2) is enrolling subjects who are symptomatic with cancer-related pain and will compare GVAX plus Taxotere to Taxotere plus prednisone. Each Phase III study is expected to enroll 600 patients and is designed to demonstrate a survival benefit compared to Taxotere plus prednisone. Cell Genesys received Special Protocol Assessments from the FDA for each of the VITAL-1 and VITAL-2 studies.