The European Medicines Agency (EMA) has launched an investigation into an increased risk of death and fractures reported in an ongoing clinical trial with the prostate cancer drug Xofigo (radium-223 dichloride).
The clinical trial is examining Xofigo versus placebo, both given in combination with Zytiga (abiraterone acetate) and prednisone/prednisolone, in asymptomatic or mildly symptomatic prostate cancer patients. A preliminary analysis of the trial data, carried out by an independent committee, reported a rate of death of 27 per cent for the Xofigo combination compared with 20 per cent for the placebo combination. Fractures also occurred more frequently with the Xofigo combination than the placebo combination – 24 per cent versus 7 per cent. Study participants are no longer being treated with Xofigo and all patients involved are being monitored closely, according to the EMA.
At the request of the European Commission, the EMA’s Pharmacovigilance Risk Assessment Committee Pharmacovigilance Risk Assessment Committee will review the full results of this clinical trial and other available data to evaluate their impact on the authorised use of Xofigo.
While the investigation is ongoing, doctors are advised not to use Xofigo in combination with Zytiga and prednisone/prednisolone to treat metastatic castration-resistant prostate cancer.