Provenge likely to be approved in Europe later this year


The European Medicines Agency’s Committee for Medicinal Products for Human Use today recommended that marketing authorization be approved for sipuleucel-T (Provenge) in the European Union. A final decision by the European Commission is likely later this year.

According to a media release issued by Dendreon, the committee recommended that Provenge be cleared to treat men with asymptomatic or minimally symptomatic, metastatic (non-visceral), castrate-resistant prostate cancer for whom chemotherapy is not yet clinically indicated.

Of course an approval in Europe does not necessarily mean that a product becomes available to patients through the national health systems of individual nations, so there is a way to go yet before we will know just how widely sipuleucel-T becomes available in Europe.

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