FDA approves Dendreon’s prostate cancer treatment

Prostate cancer

The U.S. Food and Drug Administration (FDA) today approved Seattle biotech company Dendreon’s immunotherapy treatment for prostate cancer.

The treatment, Provenge (sipuleucel-T), is indicated for the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment, the FDA said.

The treatment is an immune therapy in which a patient’s immune cells are removed and exposed to a prostate cancer protein that is linked to an immune-stimulating compound.

The exposure stimulates the immune cells to attack the cancer cells more aggressively. After the treatment, the cells are infused back into the patient.

Provenge is administered intravenously in a three-dose schedule given at about two-week intervals.

In a study of 512 men with with metastatic disease that was not responding to hormone treatment, patients who underwent Provenge treatment, showed an increase in overall survival of 4.1 months, the FDA said.

The a median survival for patients receiving Provenge treatments of 25.8 months, as compared to 21.7 months for those who did not receive the treatment.

Almost all of the patients who received Provenge had some type of adverse reaction, the FDA noted.

Common adverse reactions reported included chills, fatigue, fever, back pain, nausea, joint ache and headache.The majority of adverse reactions were mild or moderate in severity.

Serious adverse reactions, reported in approximately one quarter of the patients receiving Provenge, included some acute infusion reactions and stroke.

Prostate cancer is the second most common type of cancer among men in the United States, behind skin cancer, and usually occurs in older men.

In 2009, an estimated 192,000 new cases of prostate cancer were diagnosed and about 27,000 men died from the disease, according to the National Cancer Institute.

To learn more:

• Visit the Dendreon Web site.

• Read Sally James’ coverage of Dendreon’s Provenge in Seattle Business magazine here and here.

• Read Doughton’s article in the Seattle Times: Seattle biotech firm on verge of a groundbreaking cancer vaccine.

• Watch two lectures on UWTV: “Your Immune System vs. Cancer” by Dr. Oliver Press and “Keeping Tumors at Bay With Vaccines” by Dr. Nora Disis from the University of Washington’s Science for Life series available online here.

Tags: Dendreon, Prostate Cancer, Provenge

Category: News, Prostate Cancer