Dendreon wins Provenge authorisation
pharmafile | September 19, 2013 | News story | Research and Development, Sales and Marketing | Dendreon, Provenge, prostate cancer
Dendreon Corporation has been given the green light in the European Union for its oncology treatment Provenge in a move which should boost the company’s fortunes.
The good news comes more than three years after the drug – a cancer vaccine indicated to treat metastatic, castration-resistant prostate cancer (mCRPC) in men who have not received chemotherapy – made its US breakthrough.
Provenge (sipuleucel-T) was approved by the FDA in April 2010 but it has been a slow road for the brand since then: last year the sluggish uptake of the drug was in large part the reason for Seattle-based Dendreon slashing 600 jobs and closing its manufacturing facility in New Jersey.
“The marketing authorisation of Provenge in the EU represents an important achievement for Dendreon,” said the company’s chairman John Johnson.
“As the first personalised immunotherapy approved for the treatment of mCRPC in Europe, Provenge may help extend the lives of appropriate prostate cancer patients,” he added.
The novel therapy harnesses a patient’s own immune system to fight against their cancer and has been shown to improve overall survival compared with placebo.
The European Commission made its positive decision following data from three randomised, placebo-controlled, multi-centre late-stage studies, which took in more than 700 patients.
In the Phase III IMPACT study, median survival was 4.1 months longer for patients taking Provenge compared to those who received placebo, with similar effects found in the two other studies.
“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, Dendreon’s chief medical officer.
The company is currently enrolling patients in an open-label study in Europe.
Relatively high cost and its unusual mechanism of action have been advanced as possible reasons for Provenge’s failure to gain the foothold in the market its manufacturer might have expected.
The drug is manufactured by Dendreon at its two surviving factories in Atlanta and Seal Beach, California. Last year Provenge had revenues of $325 million.
Adam Hill
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