Dendreon Corporation (Nasdaq: DNDN) announced that the U.S. Food and Drug Administration’s (FDA) Office of Cellular, Tissue and Gene Therapies Advisory Committee recommended to the FDA that there is substantial evidence of efficacy and safety of PROVENGE (sipuleucel-T) for the treatment of patients with asymptomatic, metastatic, androgen-independent (also known as hormone refractory) prostate cancer.
If approved for marketing by the FDA, PROVENGE would become the first active cellular immunotherapy and the first biologic approved to treat prostate cancer.
The FDA will now review the advisory committee’s recommendations. The Company anticipates a decision on PROVENGE by May 15, 2007.
The Advisory Committee was asked if the submitted data established that sipuleucel-T (APC-8015) is reasonably safe and whether there is substantial evidence that the product is efficacious.
The Advisory Committee voted 17 to 0 in favor of the safety of PROVENGE in response to the question and 13 to 4 in favor of the efficacy question.
“Today marks an important milestone for men with advanced prostate cancer,” said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. “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.”
Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 218,890 new cases of prostate cancer diagnosed each year. More than 27,000 men die each year of the disease.