EMA's PRAC backs contraindications for Xofigo with Zytiga, and other news from March meeting

9 March 2018

At its March meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency recommended contraindicating the use of the prostate cancer medicine Xofigo (radium-223 dichloride) with Zytiga (abiraterone acetate) and prednisone/prednisolone, due to preliminary clinical trial results showing an increased risk of death and fractures with this combination.

Xofigo is a drug marketed by Germany’s Bayer (BAYN: DE), which is conducting a clinical trial comparing its own drug with placebo, both given in combination Johnson & Johnson’s Zytiga, and prednisone or prednisolone.

The recommendation is being sent to the European Commission for a legally binding decision. This is a temporary measure until the ongoing in-depth review of the benefits and risks of Xofigo is complete.

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