Recently, the European Medicines Agency (EMA) has recommended halting the use of the Xofigo (radium-223 dichloride) in combination with Zytiga (abiraterone acetate) and prednisone due to a possible increased risk of death and fractures.
This recommendation comes from the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) after their having reviewed preliminary data from an ongoing clinical study in metastatic prostate cancer patients. In this study, 34.7% of men treated with Xofigo, Zytiga and prednisone/prednisolone in combination have died so far, compared with 28.2% of patients given a placebo, Zytiga and prednisone/prednisolone.
They also found that more fractures have occurred in the men taking Xofigo in combination than the placebo combination (26% versus 8.1%).
This recommendation is a temporary measure while an in-depth review of the benefits and risks of Xofigo is ongoing.
Based on this recommendation, Healthcare professionals in the EU cannot use a combination of Xofigo with the anti-androgen Zytiga and prednisone. They have also been instructed to stop this combination in men currently treated with the combination. EU Healthcare professionals have also been 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), has not been established.
These are temporary measures until the ongoing in-depth review of the benefits and risks of Xofigo in combination is completed. EMA will communicate further at the conclusion of the review.
Both of these medicines can continue to be used separately, in line with the recommendations in their product information. This restriction is specific to the simultaneous use of these drugs.
Joel T. Nowak, MA, MSW wrote this Post. Joel is the CEO/Executive Director of Cancer ABCs. He is a Cancer Thriver diagnosed with five primary cancers - Thyroid, Metastatic Prostate, Renal, Melanoma, and the rare cancer Appendiceal cancer.