The US Food and Drug Administration (FDA) has approved Provenge (sipuleucel-T), an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer (CRPC). Provenge , developed by Dendreon Corporation is designed to induce an immune response against prostatic acid phosphatase (PAP), an antigen expressed in most prostate cancers, and is the first in a new therapeutic class known as autologous cellular immunotherapies.

"The US FDA approval of Provenge is a testament to the courage of the patients and researchers who participated in our studies and is the culmination of nearly 15 years of research and development by our dedicated employees," said Mitchell H Gold, president and chief executive officer of Dendreon. "The approval of Provenge is a significant step towards realizing our mission of transforming the lives of patients with cancer, and it also marks Dendreon's transformation into a commercial enterprise, ready to support the successful launch of the first personalized treatment for cancer."

Dendreon intends to make Provenge available through approximately 50 centers, all of which were approved Provenge clinical trial sites, and expects to increase capacity over the next year. The increased capacity will be a result of the anticipated licensure of its expanded New Jersey, Atlanta, Georgia and Orange County, California facilities in mid-2011.

"The approval of Provenge, the first autologous cellular immunotherapy, represents a significant scientific and clinical advancement for the treatment of prostate cancer," said Philip Kantoff, director of the Lank Center for Genitourinary Oncology, chief of the Division of Solid Tumour Oncology, and chief clinical research officer at Dana-Farber Cancer Institute, professor of Medicine at Harvard Medical School. "Cancer immunotherapies that use the patient's own immune system will likely create an entirely new treatment paradigm for patients with cancer."

Three phase-3 studies involving 737 patients were submitted to US FDA to support licensure. The pivotal study was the phase-3 IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) trial (D9902B), a 512-patient, multi-center, randomized, double blind, placebo-controlled study that evaluated men with asymptomatic or minimally symptomatic, metastatic CRPC. Provenge extended median survival beyond two-years, demonstrating a median improvement of 4.1 months compared to the control group (25.8 months versus 21.7 months). Overall, Provenge reduced the risk of death by 22.5 per cent compared to the control group (HR=0.775). Results from the similarly designed Study D9901 in asymptomatic metastatic CRPC also demonstrated a survival advantage of similar clinical magnitude as the IMPACT study.

"The approval of Provenge represents a significant advancement in the care of men with advanced prostate cancer. Provenge offers a new choice in the front line treatment for these men who - until today - had few appealing treatment options," said David Penson, professor of Urologic Surgery at Vanderbilt University Medical Center.