Radium-223 combats metastatic prostate cancer because it accumulates in bone tissues where the cancer spreads and the alpha particles it emits destroy the nearby cancer cells and help to manage related symptoms. Xofigo is classed as a radiopharmaceutical, since it contains an active radioactive substance. This verdict will then be sent to the EC, which will formulate a legally binding ruling that will be applicable in all European Union member states. PRAC’s recommendations will be sent to the EMA’s Committee for Medicinal Products for Human Use (CHMP), which will decide the EMA’s stance. Son efficacité a été démontrée versus placebo sur la survie globale (différence de +2,8 mois) et sur le délai de survenue du premier événement osseux symptomatique. The safety committee called on Bayer, the pharmaceutical company marketing the drug, to conduct further studies to explore the reasons for earlier death and increased risk of fractures reported in the study. XOFIGO a l’AMM dans le traitement du cancer de la prostate résistant à la castration, avec métastases osseuses symptomatiques et sans métastases viscérales connues. On average participants in the Xofigo group died 2.6 months earlier than those taking the placebo combination and 29% of Xofigo combination patients had fractures compared with 11% for the placebo group.
#Xofigo price trial#
The trial was investigating the safety and efficacy of combining Xofigo with Zytiga and prednisone/prednisolone in patients with no or mild symptoms currently Xofigo is only approved for those with symptomatic bone metastases.ĮRA223 showed that patients taking the Xofigo combination had a higher risk of dying earlier and witnessed more fractures than those taking a placebo.
This decision followed PRAC’s review of data from study ERA223, which was requested by the European Commission (EC) in November 2017.
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