Dendreon said today its prostate cancer drug Provenge® (autologous peripheral blood mononuclear cells activated with PAP-GM-CSF or sipuleucel-T) won marketing authorization from the European Union.

The approval will boost sales for the prostate cancer drug by allowing the commercialization of Provenge in all 28 EU countries as well as Norway, Iceland, and Liechtenstein. Last month, Dendreon reported about $73 million in Q2 sales, up from Q1 but below analyst estimates, and the company said it did not expect to surpass last year’s $325 million in sales during 2013.

Sales have struggled because of competition from prostate cancer drugs by Johnson & Johnson and Medivation, as well as Provenge’s $93,000 price tag. Dendreon has defended its pricing of Provenge by citing its novelty as a first-in-class, personalized autologous immunotherapy, its shorter duration of use than other cancer drugs, and its success in extending median overall survival beyond two years.

Provenge is indicated for asymptomatic or minimally symptomatic metastatic (nonvisceral) castrate-resistant prostate cancer in adult men for whom chemotherapy is not yet clinically indicated.

EU authorization for Provenge followed data from three randomized, multicenter Phase III studies that enrolled a total 737 patients. In the pivotal Phase III IMPACT study, median overall survival in patients taking Provenge was 4.1 months longer than in patients who received placebo. Similar effects were observed in the two studies designed to support IMPACT.

“This milestone demonstrates the importance of providing a new therapeutic option with a differing mechanism of action than other approved treatments for appropriate prostate cancer patients in the EU,” Mark Frohlich, Dendreon’s evp of research R&D and CMO said in a statement. “We continue to enroll patients in the EU open-label study, and plan to have a presence at the upcoming European Cancer Organization (ECCO) and European Society for Medical Oncology (ESMO) conferences.” 

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