Dendreon completes FDA filing for prostate-cancer drug

Dendreon said Monday it has submitted the final portion of its application to the Food and Drug Administration for approval to market its prostate cancer drug in the U.S.

The Seattle biotech company has asked the agency for a priority review of Provenge as a potentially life-saving drug. If the FDA grants the request, it would review the application for six months, instead of the usual 10 months.

Provenge is designed to stimulate a patient's immune system to attack prostate cancer cells. The company is asking for approval based mainly on a 127-patient study of men with terminal prostate cancer, which showed Provenge patients had a 4.5-month median survival edge over patients on placebo. The drug's side effects primarily involve fever and chills that last for one or two days.

About 232,000 American men are diagnosed with prostate cancer each year, and 30,000 die from the disease.