First FDA-Approved Cancer Treatment Vaccine Available at Roswell Park

BUFFALO, NY — The nation’s first FDA-approved cancer treatment vaccine, Provenge (sipuleucel-T), is being offered for the first time in Western New York at Roswell Park Comprehensive Cancer Center. The vaccine is designed for men with advanced prostate cancer who have limited treatment options and who meet eligibility requirements. “It’s the first time we are able to offer immunotherapy with an FDA-approved product,” says Roberto Pili, MD, Chief of the Genitourinary Section in Roswell Park’s Department of Medicine.

Provenge represents a new approach to cancer treatment — using vaccines to trigger the patient’s own immune system to attack cancer cells. Roswell Park patients who receive Provenge will have immune cells purified from their blood; this process will take place at the American Red Cross headquarters in Buffalo. The immune cells will then be shipped to a central lab, where they will be combined with a specific protein (an antigen) that stimulates the immune cells to recognize and kill prostate cancer cells.

The resulting vaccine, custom-created for each patient, will be shipped to Roswell Park to be administered intravenously, in three doses, approximately two weeks apart. Because the vaccine uses the patient’s own immune cells, “there are no serious allergic reactions,” notes Dr. Pili. Potential reactions include fever and flu-like symptoms, “but these are rare. This is a generally well-tolerated procedure.”

Dr. Pili says patients will be evaluated at Roswell Park to ensure that they meet the eligibility requirements. These include: a diagnosis of prostate cancer that has spread to the bones or other areas outside the prostate; few or minimal symptoms of the disease; and disease that has recurred despite treatments to reduce levels of male hormones, or androgens, which help fuel the growth of prostate cancer. A study published in the July 29, 2010, issue of The New England Journal of Medicine demonstrated that Provenge significantly extended overall survival for men in this category, whose disease is incurable.

Dr. Pili says Roswell Park researchers hope to conduct clinical trials that will combine Provenge with other types of treatment, with the goal of improving the effectiveness of the vaccine therapy. “This is just the beginning,” he says. Pamela Germain, MBA, Vice President for Managed Care and Outreach, says Roswell Park will work closely with healthcare payers to ensure that treatment costs will be preauthorized for eligible patients.

Provenge is the first FDA-approved vaccine for the treatment of cancer. For more information about Provenge eligibility and other treatment options available at Roswell Park, call 1-800-ROSWELL (1-800-767-9355).

The mission of Roswell Park Comprehensive Cancer Center is to understand, prevent and cure cancer. Roswell Park, founded in 1898, was one of the first cancer centers in the country to be named a National Cancer Institute-designated comprehensive cancer center and remains the only facility with this designation in Upstate New York. The Institute is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers; maintains affiliate sites; and is a partner in national and international collaborative programs. For more information, visit Roswell Park’s website at, call 1-800-ROSWELL (1-800-767-9355) or email

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