GVAX Receives Fast-Track Status

June 1, 2006

The FDA has granted Cell Genesys' GVAX immunotherapy fast track designation for prostate cancer. Two independent phase II trials in patients with hormone-refractory metastatic prostate cancer showed that median survival with GVAX compared favorably with that of patients treated with standard docetaxel (Taxotere)/prednisone in previous studies, the company said. Two phase III trials of GVAX have been initiated, VITAL-1 and VITAL-2. Each will enroll approximately 600 patients.

SOUTH SAN FRANCISCO, Calif—The FDA has granted Cell Genesys' GVAX immunotherapy fast track designation for prostate cancer. Two independent phase II trials in patients with hormone-refractory metastatic prostate cancer showed that median survival with GVAX compared favorably with that of patients treated with standard docetaxel (Taxotere)/prednisone in previous studies, the company said. Two phase III trials of GVAX have been initiated, VITAL-1 and VITAL-2. Each will enroll approximately 600 patients.