After a troubled time across the pond, Dendreon has been granted European marketing authorisation for its prostate cancer vaccine Provenge. The immunotherapy, also known as sipuleucel-T, got the final approval from the European Commission yesterday, following recent thumbs-ups from the EMA's Committee for Advanced Therapy (CAT) and the Committee for Medicinal Products for Human Use (CHMP).
The marketing authorisation was granted off the back of three Phase III studies, enrolling 737 patients. The pivotal IMPACT study showed that patients who received Provenge versus placebo had a median survival of 4.1 months longer.
Despite offering a novel approach to the treatment of prostate cancer, Provenge has struggled with US sales since FDA approval in 2010. While Dendreon now has approval to sell Provenge in all 28 EU countries as well as Norway, Iceland and Liechtenstein, the question is whether the immunotherapy will sell. The cancer vaccine faces some stiff competition in the market, and the high price it commands in the US (~$93,000) may be prohibitive to sales.
Read the press release from Dendreon >
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