(Reuters) Prostate cancer vaccine Provenge has long incited passions unlike any other cancer therapy. Doctors who raised doubts about it received death threats. Health regulators and lawmakers faced loud protests at their offices. A physician at the American Cancer Society was so intimidated by Provenge partisans that he yanked a skeptical discussion of it from his blog. The vitriol dissipated in April 2010, when the U.S. Food and Drug Administration approved Provenge for advanced prostate cancer, satisfying investors in manufacturer Dendreon and patients who for years had demanded it be put on the market. ...Read more at Reuters.
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NOTE: Dendreon’s comment regarding the Reuters article.
The Journal of the National Cancer Institute recently published an article regarding the pivotal IMPACT trial in which PROVENGE® (sipuleucel-T) demonstrated a significant improvement in overall survival (OS) in patients with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer.
With the U.S. Food and Drug Administration (FDA) approval of PROVENGE, the first autologous cellular immunotherapy designed to stimulate the immune system to identify and attack prostate cancer, we have introduced an entirely new cancer treatment paradigm. The FDA approval was based on a significant improvement in overall survival shown in three well-designed, randomized, double-blind, controlled clinical trials – including the pivotal IMPACT trial – with remarkably consistent results shown across the trials as well as in numerous patient subgroups.
The PROVENGE clinical data have undergone a rigorous scientific review process that included FDA review process, a Center for Medicare and Medicaid Services (CMS) national coverage determination, a Technology Assessment and the peer review of multiple publications.
As evidenced by the FDA approval, CMS national coverage decision, and NCCN treatment guidelines, the PROVENGE data clearly demonstrated a significant patient survival benefit and support its use as a clinically meaningful treatment option for certain types of advanced prostate cancer.
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NOTE: Dendreon’s comment regarding the Reuters article.
The Journal of the National Cancer Institute recently published an article regarding the pivotal IMPACT trial in which PROVENGE® (sipuleucel-T) demonstrated a significant improvement in overall survival (OS) in patients with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer.
With the U.S. Food and Drug Administration (FDA) approval of PROVENGE, the first autologous cellular immunotherapy designed to stimulate the immune system to identify and attack prostate cancer, we have introduced an entirely new cancer treatment paradigm. The FDA approval was based on a significant improvement in overall survival shown in three well-designed, randomized, double-blind, controlled clinical trials – including the pivotal IMPACT trial – with remarkably consistent results shown across the trials as well as in numerous patient subgroups.
The PROVENGE clinical data have undergone a rigorous scientific review process that included FDA review process, a Center for Medicare and Medicaid Services (CMS) national coverage determination, a Technology Assessment and the peer review of multiple publications.
As evidenced by the FDA approval, CMS national coverage decision, and NCCN treatment guidelines, the PROVENGE data clearly demonstrated a significant patient survival benefit and support its use as a clinically meaningful treatment option for certain types of advanced prostate cancer.
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