Dendreon shares surge on Provenge EU marketing approval
US biotech firm Dendreon (Nasdaq: DNDN) says that the European Commission has granted marketing authorization for Provenge (autologous peripheral blood mononuclear cells activated with PAP-GM-CSF or sipuleucel-T) for the treatment of prostate cancer. The company’s shares surged as much as 14% on the news, closing yesterday up 5% at $3.10.
The drug is indicated in the European Union for 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’s 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 Liechtenstein.
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