Dendreon Reports Marketing Authorization For PROVENGE In EU - Quick Facts

(RTTNews) - Dendreon Corp. (DNDN) said the European Commission (EC) has granted marketing authorization for PROVENGE dispersion for infusion in the European Union or 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 or EMA Committee for Advanced Therapy and the Committee for Medicinal Products for Human Use urging 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. The European marketing authorization for PROVENGE was granted based on data from three randomized, placebo-controlled, multi-center Phase III trials, enrolling 737 patients.

PROVENGE is intended solely for autologous use and should under no circumstances be administered to other patients.