Dendreon Reports Marketing Authorization for Provenge in EU
Dendreon Corporation (Nasdaq: DNDN) today announced that
the European Commission (EC) has granted marketing authorization for
PROVENGE^® (autologous peripheral blood mononuclear cells activated with
PAP-GM-CSF or sipuleucel-T) dispersion for infusion 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 (EMA)
Committee for Advanced Therapy (CAT) and the Committee for Medicinal Products
for Human Use (CHMP) recommending that PROVENGE be granted marketing
authorization in the EU.
The marketing authorization provides approval for the commercialization of
PROVENGE in all 28 countries of the EU as well as Norway, Iceland and
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