EU approves Provenge for Prostate Cancer

Dendreon Corporation has announced that the European Commission (EC) has granted marketing authorization on 17 September 2013 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 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.