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GVAX Receives Fast-Track Status

GVAX Receives Fast-Track Status

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.

 
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