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.