Dendreon has announced that the European Commission ( EC ) has granted marketing authorization for Provenge ( autologous peripheral blood mononuclear cells activated with PAP-GM-CSF or Sipuleucel-T ) dispersion for infusion in the European Union ( EU ) 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.
This final decision by the EC follows recent positive opinions from both the European Medicines Agency ( EMA ) Committee for Advanced Therapy ( CAT ) and the Committee for Medicinal Products for Human Use ( CHMP ).
The marketing authorization provides approval for the commercialization of Provenge in all 28 countries of the European Union as well as Norway, Iceland and Liechtenstein.
The European marketing authorization for Provenge was granted based upon data from three randomized, placebo-controlled, multi-center Phase III studies, which enrolled 737 patients.
In the pivotal Phase III IMPACT study, an improvement in overall survival was observed, with a median survival of 4.1 months longer in patients who received Provenge versus those who received placebo ( hazard ratio, HR=0.775, 95%-CI 0.614, 0.979, P =0.032 ). Similar effects were observed in the two supportive studies.
Provenge is an immunotherapy that stimulates the immune system to kill cancer cells. It contains immune cells that are extracted from the patient’s blood. These cells are then mixed outside the patient’s body with a fusion protein, which is taken up by the cells. The fusion protein consists of prostatic acid phosphatase ( PAP ), a molecule found in most prostate cancer cells, attached to granulocyte-macrophage colony-stimulating factor ( GM-CSF ), a molecule that activates immune cells. When the immune cells are infused back into the patient, they stimulate an immune response against PAP, resulting in the immune system attacking and killing prostate cancer cells because they contain PAP.
Provenge is intended solely for autologous use and should under no circumstances be administered to other patients.
The safety evaluation of Provenge was based on data from 601 prostate cancer patients in four randomized clinical trials and post-marketing surveillance.
Provenge should be delayed in patients with active systemic infection until resolution and used with caution in patients with a history of embolic and thrombotic events, including cerebrovascular disease and cardiovascular disorders.
Serious adverse reactions reported include acute infusion reactions ( occurring within 1 day of infusion ), catheter sepsis, staphylococcal bacteremia, myocardial infarction and cerebrovascular events.
The most commonly reported adverse reactions were chills, fatigue, pyrexia ( fever ), nausea, arthralgia, headache, and vomiting. ( Xagena )
Source: Dendreon, 2013