The USFDA’s Office of Cellular, Tissue and Gene Therapies Advisory Committee has recommended the PROVENGE® (sipuleucel-T) for the treatment of patients with asymptomatic, metastatic, androgen-independent (or hormone refractory) prostate cancer.
The committee found that there is substantial evidence of efficacy and safety of PROVENGE® (sipuleucel-T) in the abovementioned patient population.
According to Mitchell H. Gold, M.D., president and chief executive officer of Dendreon:
"Today marks an important milestone for men with advanced prostate cancer. If approved, PROVENGE could become a breakthrough treatment for patients with advanced prostate cancer who currently have few treatment options. We look forward to working closely with the FDA."
Once the FDA grants marketing approval, PROVENGE® will become the first active cellular immunotherapy and the first biologic approved to treat prostate cancer. The committee’s recommendations will now be reviewed by the USFDA.
Dendreon Corporation (Nasdaq: DNDN) – maker of PROVENGE® - is expecting a decision by May 15, 2007.
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