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19-03-2018 | Prostate cancer | News | Article

Regulatory update

EMA issues warning for radium-223 dichloride in prostate cancer

medwireNews: The EMA has recommended against the concomitant use of radium-223 dichloride in men who are receiving abiraterone acetate plus prednisone/prednisolone for prostate cancer.

The EMA’s Pharmacovigilance Risk Assessment Committee has introduced the contradiction as a temporary measure while a comprehensive review of the risk–benefit profile of radium-223 dichloride is conducted.

The guidance follows an analysis of an ongoing placebo-controlled trial assessing the addition of radium-223 dichloride to the CYP17A1 inhibitor abiraterone and prednisone/prednisolone in the setting of metastatic prostate cancer. Thus far, the mortality rate in the radium-223 dichloride group is higher than in the placebo group, at 34.7% versus 28.2%, and so is the incidence of fractures, with corresponding rates of 26.0% and 8.1%.

Healthcare professionals are advised to cease treatment in any patients currently receiving the combination and to review the treatment options.

The EMA also stresses that the safety and efficacy of radium-223 dichloride in combination with another anti-androgen agent enzalutamide is currently unknown.

By Shreeya Nanda

medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group

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