A successful trial of such patients could significantly expand the market for Provenge. The trial isn't required to gain approval for Provenge in Europe, Gold says.
Status of European Regulatory Approval
Dendreon has commenced patient enrollment and initiation of treatment for the Provenge European Union (EU) open-label study, which is being conducted in European men with metastatic castrate-resistant prostate cancer (mCRPC) to describe product release parameters and report on safety in a European population. The study may enroll up to 45 patients in four sites across the EU. Dendreon has submitted a marketing authorization application (MAA) for Provenge, which is currently under review by the European Medicines Agency (EMA). The decision is expected in mid-2013 and should be favorable because of the proven success of the treatment. The approval should be a major price catalyst and provide the company with a stronger bargaining position with potential partners.
Dendreon plans to introduce provenge in the European market in 2013. Dendreon submitted the marketing authorisation application to the EMA (European Medicines Agency) in early 2012.
EMA expected decision May 2013.