SEATTLE, Jan. 16 (UPI) -- Dendreon said Tuesday the U.S. Food and Drug Administration granted priority review status for Provenge, a prostate cancer treatment.
Dendreon is seeking an indication as a treatment for asymptomatic, metastatic, hormone refractory prostate cancer. The FDA set an action date for Provenge of May 15, 2007.
"Clinical trials have shown that Provenge increases survival and is generally well tolerated in men with late-stage prostate cancer, a highly prevalent disease for which there are currently few available treatment options," said Mitchell H. Gold, Dendreon's president and chief executive officer.
The company's biologics license application is based on Study D9901, a phase 3 study that found an improvement in overall survival in patients receiving Provenge.
