On September 27th Dendreon announced that it has enrolled and started its first patient with metastatic advanced prostate cancer that is castrate resistanr in a European Union based clinical trial of Provenge. Finally, men in the EU can hope that in the near future that Provenge could become available to them.
The trial is hoped to demonstrate that Provenge is safe for European men and extends their life. Current plans call for up to 45 men to enroll in the study in four different sites in the EU.
Dendreon has submitted a marketing authorization application (MAA) for sipuleucel-T which is currently under review by the European Medicines Agency (EMA). Sipuleucel-T, or Provenge, is currently approved only in the United States.
“We are extremely pleased with the progress of this new study and that the first patient has begun his treatment,” said Thomas Powles MD, MRCP, Barts Cancer Institute, St. Bartholomew’s Hospital, London. “We are also excited about the potential study outcomes and look forward to a successful program with the support of our committed clinical team and dedicated patients.”
If it iseventually approved we can only hope that the insurance systems in the Union agree to pay for the treatment.
We all hope that soon our European brothers will be able to join us and put Provenge into their treatment plans.
Joel T. Nowak, M.A, M.S.W.