Dendreon Receives Positive Opinion for Provenge

barbara.lempert

for ® in the European Union

SEATTLE–(BUSINESS WIRE)– June 28, 2013–Dendreon Corporation (Nasdaq: DNDN) today announced that the EuropeanMedicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinionrecommending 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 symptomaticmetastatic (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 usingthe body’s own immune system to fight cancer, PROVENGE is a novel therapy that addresses a genuine unmet patient need. Ifapproved, 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 marketingauthorization application for PROVENGE in the EU. A regulatory decision is anticipated from the EC in the second half of thisyear.

“PROVENGE is the first immunotherapy to have demonstrated an overall survival improvement in prostate cancer. The positiveCHMP opinion for PROVENGE is great news for advanced prostate cancer patients and physicians in Europe, and we lookforward to the European Commission’s final decision on this novel treatment option,” said Prof. Karim Fizazi, M.D., Ph.D. Head ofthe Department of Cancer Medicine, The Institut Gustave Roussy, Villejuif, and Full Professor in Oncology, the University…Read more

Pharmalive – The Pulse of the Pharmaceutical Industry

Share This Post

Related Articles

Leave a Reply

© 2018 Global Regulatory Science. All rights reserved. Site Admin · Entries RSS · Comments RSS