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Dendreon's cancer vaccine wins EU approval

Provenge approved for use in prostate cancer three years after US recommendation

Dendreon Provenge prostate cancer 

Dendreon has finally won marketing authorisation in the EU for it oncology treatment Provenge three years after the drug was first approved by the US Food and Drug Administration (FDA).

The European Commission confirmed an earlier recommendation from the European Medicines Agency (EMA) for use of Provenge (sipuleucel-T) for the treatment of patients with metastatic castrate resistant prostate cancer for whom chemotherapy is not yet clinically indicated and who have experience minimal symptoms.

Upon its approval in the US in 2010, Provenge was touted as the first cancer 'vaccine' approved by the FDA due to its treatment mechanism of using a patient's own immune system to induce a response to fight the cancer.

Sales of the treatment got off to a slow start, however, reaching just $213.5m during 2011, despite Provenge demonstrating in clinical trials that it can extend patient survival by four months.

At the company's annual report in 2011, Dendreon's CEO John Johnson explained that it wasn't easy to introduce an entirely new treatment paradigm, while the high cost of Provenge - $93,000 for a full course of treatment – due to being tailored for each individual patient has also been a factor in its lack of uptake, according to some critics.

Sales have picked up in recent months, with net revenues of $325.3m during 2012, although last year Dendreon implemented a cost-cutting programme that included the loss of 600 jobs and the closure of its manufacturing facility in Morris Plains, New Jersey.

Approval in Europe is a boost for the company though, and will allow access to a new market of prostate cancer patients.

"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," said Mark Frohlich, executive VP of research and development and chief medical officer of Dendreon.

Article by
Thomas Meek

18th September 2013

From: Sales



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