Xofigo was authorised in the European Union in November 2013. The ongoing study of Xofigo in combination with Zytiga and prednisone/prednisolone included patients with castration-resistant prostate cancer that has spread mainly to the bones, who have no symptoms or only mild symptoms and who have not been treated with chemotherapy. It is authorised for use when medical or surgical castration (stopping the production of male hormones in the body using medicines or surgery) does not work, and when the cancer has spread to the bones and is causing symptoms such as pain but is not known to have spread to other internal organs.
Xofigo is used to treat adult men with cancer of the prostate (a gland of the male reproductive system). Further information will be made available once an ongoing review of the evidence is complete.The safety and efficacy of Xofigo in combination with second generation androgen receptor antagonists such as Xtandi (enzalutamide) have not been established.Xofigo must not be used with the anti-androgen Zytiga (abiraterone acetate) and prednisone/prednisolone because of possible increased risk of fractures and mortality.
If you are being treated with Xofigo and have any questions, you should contact your doctor.Both medicines can continue to be used separately, in line with the recommendations in their product information.If you are currently being treated with this combination, your doctor will alter your treatment.Doctors are being advised that the medicine for prostate cancer Xofigo must not be used with the prostate cancer medicine Zytiga and prednisone/prednisolone because there is evidence that the combination may be harmful to patients due to a possible increased risk of fractures and death.EMA will communicate further at the conclusion of the review. These are temporary measures until the ongoing in-depth review of the benefits and risks of Xofigo is complete. Healthcare professionals are also warned that the safety and efficacy of Xofigo in combination with a class of medicines called second generation androgen receptor antagonists, such as Xtandi (enzalutamide), have not been established. Healthcare professionals in the EU must not use a combination of Xofigo with the anti-androgen Zytiga and prednisone/prednisolone, and should stop this combination in men currently treated with it and review the treatment for these patients. Patients have completed the Xofigo part of the study, and the combination is no longer being used all the patients involved are being monitored closely. The ongoing clinical study includes metastatic prostate cancer patients who have not previously received chemotherapy and who have no symptoms or only mild symptoms, such as pain.
Xofigo is currently authorised for use in men whose prostate cancer has spread to the bones and is causing symptoms. In view of the seriousness of the events reported, the PRAC has taken action by introducing a contraindication as a temporary measure to protect patients' safety while an in-depth review of the benefits and risks of Xofigo is ongoing. In this study 34.7% of patients treated with Xofigo, Zytiga and prednisone/prednisolone have died so far, compared with 28.2% of patients given placebo, Zytiga and prednisone/prednisolone.įractures have also occurred more frequently with the Xofigo combination than the placebo combination (26% versus 8.1%). The European Medicines Agency (EMA) has recommended contraindicating the use of the prostate cancer medicine Xofigo (radium-223 dichloride) with Zytiga (abiraterone acetate) and prednisone/prednisolone, due to an increased risk of death and fractures with this combination.ĮMA's Pharmacovigilance Risk Assessment Committee ( PRAC) has reviewed the preliminary data from an ongoing clinical study in metastatic prostate cancer patients. Ongoing clinical study shows an increased risk of death and fractures with the combination
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