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FDA Approves PROVENGE(R) for the Treatment of Men with Advanced Prostate Cancer
Date:4/29/2010

e first autologous cellular immunotherapy, represents a significant scientific and clinical advancement for the treatment of prostate cancer," said Philip Kantoff, M.D., Director of the Lank Center for Genitourinary Oncology, Chief of the Division of Solid Tumor 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."

Clinical Trial Results Supporting FDA Approval

Three Phase 3 studies involving 737 patients were submitted to 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 percent 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, M.D., Professor of Urologic Surgery at Vanderbilt University Medical Center.


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