June 28, 2013--Dendreon Corporation (Nasdaq: DNDN) today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending that PROVENGE
(autologous peripheral blood mononuclear cells activated with PAP-GM-CSF or Sipuleucel-T) be granted marketing authorization 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. The CHMP’s recommendation follows a positive recommendation by the Committee for Advanced Therapy (CAT).
“We are pleased with this outcome and look forward to a final regulatory decision by the European Commission later this year,” said Mark Frohlich, Executive Vice President of Research and Development and Chief Medical Officer of Dendreon. “By using the body’s own immune system to fight cancer, PROVENGE is a novel therapy that addresses a genuine unmet patient need. If approved, PROVENGE would help extend the lives of appropriate prostate cancer patients in Europe.”
The CHMP will make a final recommendation to the European Commission (EC) within the coming months on the marketing authorization application for PROVENGE in the EU. A regulatory decision is anticipated from the EC in the second half of this year.
“PROVENGE is the first immunotherapy to have demonstrated an overall survival improvement in prostate cancer. The positive CHMP opinion for PROVENGE is great news for advanced prostate cancer patients and physicians in Europe, and we look forward to the European Commission’s final decision on this novel treatment option,” 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.
John H. Johnson, Dendreon’s chairman, president and chief executive officer, said, “This recommendation represents a significant milestone for Dendreon as we advance the global market opportunity for PROVENGE. We are finalizing our plans for a capital-efficient launch in Europe, including evaluating our partnering options. We look forward to bringing the innovative treatment of PROVENGE to patients around the world."