Dendreon Corp has received a boost from regulators in Europe who have given the green light to the US firm’s prostate cancer immunotherapy Provenge.
Specifically, the European Commission has granted marketing authorisation for Provenge (sipuleucel-T) for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer in adults in whom chemotherapy is not yet clinically indicated. It will now be available in all 28 countries of the European Union as well as Norway, Iceland and Liechtenstein.
Approved by the US Food and Drug Administration in April 2010 to much fanfare, Provenge is an autologous cellular immunotherapy, whereby each dose is manufactured by obtaining a patient’s immune cells which are then exposed to a protein found in most prostate cancers. After this process, the cells are returned to the patient to treat the cancer.
Some observers had predicted that Provenge would be a blockbuster but it is still someway off that status. It has struggled to compete with more conventional treatments that were later entrants to the prostate cancer market, ie Johnson & Johnson’s Zytiga (abiraterone) and Medivation and Astellas’ Xtandi (enzalutamide), not least because of its high price (originally $93,000).
In August, Dendreon said that this year’s sales of Provenge will not top the 2012 figure of $321.5 million but it will now be hoping that European doctors and patients will be more open to using immunotherapy. Chief executive John Johnson said the marketing authorization in the European Union “represents an important achievement for Dendreon”.
The company quoted Karim Fizazi of the University of Paris as saying that “with sipuleucel-T, we have the potential to create a new treatment paradigm in advanced prostate cancer”. Dendreon R&D chief Mark Frohlich added that the company will have a presence at the upcoming European Cancer Congress in Amsterdam.