FDA GRANTS FAST TRACK STATUS FOR PROSTATE CANCER TREATMENT

Cell Genesys has received FDA fast track designation for its GVAX immunotherapy for prostate cancer, potentially expediting approval of its biologics license application, the company said.

GVAX immunotherapy is a whole cell product designed to stimulate the immune system's response against tumors. It uses two prostate cancer cell lines that have been modified to secrete a hormone known to play a key role in immune system stimulation. It is currently in a Phase III trial.

Fast track designation, mandated by the FDA Modernization Act of 1997, is given to products with the potential to treat serious or life-threatening conditions and can address unmet medical needs.