WASHINGTON — The U.S. Food and Drug Administration is not planning to seek advice from its outside advisers over Dendreon Corp.'s experimental prostate cancer vaccine, Reuters reported March 5.
The vaccine, Provenge, would be the first cancer vaccine aimed at treating a condition, rather than preventing a disease as traditional vaccines do.
The closely watched product could be a blockbuster for the biotech company, which has said it would ramp up production to handle an expected $1.2 billion to $2.5 billion of annual sales by late 2011.
Prostate cancer is diagnosed in one of every six American men and is the second-leading cause of cancer death among men.
The FDA often seeks advice on whether to approve products from its panels of outside experts and usually, but not always, follows their recommendations.
"There is not going to be an advisory committee meeting," FDA spokeswoman Shelly Burgess said March 5.
The agency is expected to decide by May 1 whether to approve Provenge sales, and the company has consistently said it doesn't expect another panel would be needed in the drug's review.
An FDA advisory panel that met in May 2007 said Dendreon provided favorable efficacy and safety results from an earlier study of Provenge. The FDA declined to approve the product, however, until data from the Impact trial confirmed earlier trends.
On March 3 Dendreon said updated results for a Phase III study of Provenge showed it extended overall survival of men with metastatic castrate-resistant forms of the disease.
The study enrolled 512 men with prostate cancer that had spread after earlier treatment with hormone-blocking agents. Men who got Provenge lived a median of 4.1 months longer than those in the control group who got a placebo — the same differential Dendreon reported last year.
This new finding was reached after 36.5 months of follow-up time, or about an extra 2.4 months of follow-up beyond what Dendreon reported last April at the American Urological Association meeting. The new results are being presented at the American Society of Clinical Oncology’s Genitourinary Cancers Symposium in San Francisco.
The data was presented March at the American Society of Clinical Oncology meeting in San Francisco.