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September 17, 2013 – Dendreon Corporation (Nasdaq: DNDN) today announced that the European Commission (EC) has granted marketing authorization for PROVENGE
® (autologous peripheral blood mononuclear cells activated with PAP-GM-CSF or sipuleucel-T) dispersion for infusion in the European Union (EU) for the treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated. This final decision by the EC follows recent positive opinions from both the European Medicines Agency (EMA) Committee for Advanced Therapy (CAT) and the Committee for Medicinal Products for Human Use (CHMP) recommending that PROVENGE be granted marketing authorization in the EU.
The marketing authorization provides approval for the commercialization of PROVENGE in all 28 countries of the EU as well as Norway, Iceland and Liechtenstein.
John H. Johnson, chairman, president and chief executive officer of Dendreon said, “The marketing authorization of PROVENGE in the EU represents an important achievement for Dendreon. As the first personalized immunotherapy approved for the treatment of mCRPC in Europe, PROVENGE may help extend the lives of appropriate prostate cancer patients.”
“With sipuleucel-T, we have the potential to create a new treatment paradigm in advanced prostate cancer, with the integration of this novel therapy to harness a patient’s own immune system to fight their cancer,” said Prof. Karim Fizazi, M.D., Ph.D., Head of the Department of Cancer Medicine, The Institut Gustave Roussy, Villejuif, and Full Professor in Oncology, the University of Paris, France.
The European marketing authorization for PROVENGE was granted based upon data from three randomized, placebo-controlled, multi-center Phase III studies, which enrolled 737 patients. In the pivotal Phase III IMPACT study, an improvement in overall survival (OS) was observed, with a median survival of 4.1 months longer in patients who received PROVENGE versus those who received placebo (HR=0.775, 95%-CI 0.614, 0.979, P =0.032). Similar effects were observed in the two supportive studies.