欧州医薬品庁(EMA)の医薬品安全監視リスク評価委員会(PRAC)が、塩化ラジウム-223について、難治性の転移性前立腺がんの三次治療以降における適応を推奨【ESMO】

EMA PRAC Recommends Restricting Use of Prostate Cancer Medicine Radium-223 Dichloride

放射線医薬品である同薬は、わが国では2016年5月に「骨転移のある去勢抵抗性前立腺がん」に対して薬価収載されている。


 


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. 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 abiraterone acetate (Zytiga) 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.

 


 


 

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