The vote of the advisory panel resulted in 13 approvals and 4 disapprovals, with the 13 approving members believing that treatment for these patients by using Provenge (Dendreon, Seattle, WA) was proven to have "substantial evidence of efficacy and safety" to extend survival according to the study trial results.
The entire panel voted that the drug was safe.
According to Dendreon's President/CEO, Dr. Mitchell H. Gold, "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."
The FDA still has the final word on the recommendation of its advisors, and although the advice is usually followed, the deadline for the FDA to decide this matter is May 15.
One of the dissenting voters on the advisory panel felt that approval of the vaccine would give patients a false sense of hope.
The most common form of non-skin cancer in the U.S. is prostate cancer, which ranks third in the world. There are greater than 1 million men who currently have prostate cancer. Every year, nearly 219,000 new cases are diagnosed and this type of cancer claims the lives of more than 27,000 men annually, according to Dendreon's press release.
