It was announced today by Dendreon Corp. that the European Commission (EC) has granted marketing authorization for Provenge 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 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.
This approval covers the commercialization of Provenge in all 28 countries of the EU as well as Norway, Iceland and Liechtenstein. This marketing authorization was granted based on data from three randomized, placebo-controlled, multi-center Phase III trials, enrolling 737 men.
Now our European brothers with advanced prostate cancer will have another treatment available for them. Let us hope that the powers that be in the EU will not throw up additional roadblocks because of the high cost of the treatment.
I can also hope that men in the EU will be more flexible in their understanding that Provenge will not drop their PSA and halt disease progression while they get the treatment.
It still remains unclear where in Europe Provenge will be manufactured. The making of Provenge is a costly and complex process that requires very special facilities and logistics to insure that it is safe, pure and delivered on time.
Joel T. Nowak, M.A., M.S.W.