Medicine should only be used after two previous treatments or when other treatments cannot be taken
EMA’s safety committee PRAC has recommended restricting the use of the cancer medicine Xofigo (radium-223 dichloride) to patients who have had two previous treatments for metastatic prostate cancer (prostate cancer that has spread to the bone) or who cannot receive other treatments.
These restrictions follow a review of data from a study suggesting that patients given Xofigo seemed to be at risk of dying earlier and had more fractures than patients given placebo (a dummy treatment). The study included patients with no or only mild symptoms, whereas Xofigo is only authorised in patients with symptoms. In the study, patients given Xofigo with Zytiga (abiraterone acetate) and prednisone/prednisolone died on average 2.6 months earlier than those given placebo with Zytiga and prednisone/prednisolone. In addition, 29% of patients who received the Xofigo combination had fractures, compared with 11% of patients given placebo.
It is thought that Xofigo, which is taken up by the bone, accumulates at sites where the bone is already damaged, for example by osteoporosis or micro-fractures, increasing the risk of fracture. However, the reasons for a possible earlier death in this study are not fully understood.
The PRAC also confirmed its previous interim recommendation that the medicine must not be used with Zytiga and prednisone/prednisolone.
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