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news.Cell Genesys' GVAX immunotherapy has been granted fast track designation by the FDA for the treatment of advanced prostate cancer. The designation should accelerate the regulatory process for the drug and potentially bring it to market earlier.
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GVAX was given the designation as it has shown potential to treat advanced prostate cancer, a life-threatening condition that represents an unmet medical need.
The treatment is currently being studied in two phase III clinical trials expected to enroll approximately 1,200 patients with metastatic hormone-refractory prostate cancer (HRPC). The trial represents one of the largest phase III clinical programs ever conducted in men with advanced prostate cancer.
“We continue to hope that GVAX immunotherapy for prostate cancer may some day offer an improved and less toxic treatment alternative to chemotherapy for patients with this disease,” stated Dr Joseph Vallner, president and COO of Cell Genesys.