GVAX Receives Fast-Track Status
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, CalifThe 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.
Prolaris in Practice: Guiding ADT Benefits, Clinical Application, and Expert Insights From ACRO 2025
April 15th 2025Steven E. Finkelstein, MD, DABR, FACRO discuses how Prolaris distinguishes itself from other genomic biomarker platforms by providing uniquely actionable clinical information that quantifies the absolute benefit of androgen deprivation therapy when added to radiation therapy, offering clinicians a more precise tool for personalizing prostate cancer treatment strategies.
