It was announced today 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. This positive CHMP’s recommendation follows a similar positive recommendation by the Committee for Advanced Therapy (CAT).

Mark Frohlich, Executive Vice President of Research and Development and Chief Medical Officer of Dendreon said, “We are pleased with this outcome and look forward to a final regulatory decision by the European Commission later this year.”

Provenge uses the body’s own immune system to fight prostate cancer extending a man’s life. If it is ultimately approved Provenge will technically be available to men living in the European Union. However, Dendreon will ultimately still need to build a plant in Europe as the manufacturing of the therapy or find a marketing partner to take care of that responsibility.

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 formal regulatory decision from the EC is anticipated in the second half of this year.

Joel T Nowak, M.A., M.S.W.