US-based biotechnology company Dendreon (DNDN) has received European Commission (EC) approval to market its prostate cancer therapy Provenge (sipuleucel-T) in the European Union (EU).
Provenge, which is a therapeutic cancer vaccine for prostate cancer (CaP), is intended 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.
The European Medicines Agency (EMA) Committee for Advanced Therapy (CAT) and the Committee for Medicinal Products for Human Use (CHMP) have recently provided positive opinions for marketing Provenge in the EU.
The marketing authorisation will see Provenge commercialised in all 28 countries of the EU and also in Norway, Iceland and Liechtenstein.
Dendreon chairman, president and CEO John Johnson said: "As the first personalised immunotherapy approved for the treatment of mCRPC in Europe, PROVENGE may help extend the lives of appropriate prostate cancer patients."
The Institut Gustave Roussy’s Department of Cancer Medicine head Karim Fizazi said: "With sipuleucel-T, we have the potential to create a new treatment paradigm in advanced prostate cancer, with the integration of this novel therapy to harness a patient’s own immune system to fight their cancer."
Provenge received the European marketing authorisation based on the data secured from three randomised, placebo-controlled, multi-centre Phase III studies, which enroled 737 patients.
Dendreon executive vice-president of research and development Mark Frohlich said: "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."
According to the company, Provenge is intended only for autologous use and it should be delayed in patients with active systemic infection until resolution, while it should be used with caution in patients with a history of embolic and thrombotic events, including cerebrovascular disease and cardiovascular disorders.
Provenge previously received US Food and Drug Administration (FDA) approval in April 2010.
Image: Micrograph showing prostatic acinar adenocarcinoma. Photo: courtesy of Nephron.