FDA Approval of New Prostate Treatment Shows Promise of Cancer Immunotherapy


(Milwaukee, WI – April 29, 2010) – According to the International Society for Biological Therapy of Cancer (sitc), the U.S. Food and Drug Administration approval of Dendreon's Provenge® (sipuleucel-T) to treat certain men with advanced prostate cancer marks a significant advance in the development of biological therapy (also called immunotherapy) for cancer treatment. Provenge is the first product approved in a new therapeutic class known as active cellular immunotherapies.

“This is an important milestone in cancer therapy research,” says Bernard Fox, Ph.D., president of sitc and chief, Molecular and Tumor Immunology, Earle A. Chiles Research Institute, Providence Portland Cancer Center. “For more than a century, medical scientists have been searching for a better way to harness the patient’s immune system in fighting cancer. Until the past few years, finding an effective cancer-specific immunotherapy eluded researchers. The development of this new immunotherapy for prostate cancer is not only a landmark event it’s also a beacon signaling the arrival of a new era in cancer immunotherapy research and application.”

The sitc is the leading U.S. medical association fostering the development of biological therapy for cancer treatment, Dr. Fox notes. “Since we were founded in 1984, our primary role has been supporting continuing education in the field. Our mission is to improve cancer patient outcomes by advancing the science, development and application of biological therapy.”

The sitc focuses on exchanging, encouraging and promoting information about developments in biological therapies for treating cancer patients among bench scientists, researchers, clinicians and students.

“The society was founded on the belief that new biologic systemic treatments would complement traditional surgery, radiation, chemotherapy and targeted therapies and join the mainstream in the fight against cancer,” Dr. Fox says. “These recent advances in immunology and biology have opened new horizons in cancer therapy, with an upsurge in the integration of new biologic agents into clinical practice.”

Clinical trials of Provenge have demonstrated a statistically significant improvement in overall survival of men with metastatic castrate-resistant prostate cancer (CRPC). The results from a Phase 3 IMPACT study of 512 men reported that, compared with a placebo, Provenge increased three-year survival by 38 percent, and extended median survival by 4.1 months, with a 22.5 percent reduction in the risk of death. (IMPACT is an acronym for Immunotherapy for Prostate AdenoCarcinoma Treatment.)

“The approval of this treatment supports our members’ ongoing research and investigation of immunotherapy as an innovative cancer treatment vehicle,” Dr. Fox says. “This new treatment option is good news for thousands of prostate cancer patients whose cancer has been resistant to other therapies.”

According to the American Cancer Society, prostate cancer is the most common non-skin cancer among men in the United States and the third most common cancer worldwide. More than 1 million men in the United States have prostate cancer. An estimated 192,280 new cases were expected to be diagnosed in 2009, and approximately 27,360 men were expected to die that year from the disease.

Provenge is part of a new therapeutic class known as active cellular immunotherapies, which uses live human cells from the patient to stimulate and boost the patient’s immune system to attack the cancer cells.

As part of the Society’s mission, sitc is dedicated to the translation of these types of new therapies to promote the application and understanding of biological therapy/immunotherapy for cancer treatment. To facilitate the rapid dissemination of information in these areas and to expedite the safe transfer of both basic and applied research to the clinical setting, sitc plans to expand and enhance its implementation of programs aimed at educating clinical oncologists and cancer surgeons about the proper timing and use of immunotherapies as they become more readily available.

The International Society of Biological Therapy of Cancer (sitc) is a 501 (c) 3 non-profit organization of clinicians, researchers, students, post-doctoral fellows and allied health professionals dedicated to improving cancer treatment outcomes by advancing the development and application of biological therapy/immunotherapy through interaction, innovation, translation and leadership. For more information about the society, please visit www.sitcancer.org.