Newsletter Stabilis, March 2018
Find inluded a report about the BOPA Congress, Oct. 2017
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Prostate cancer medicine Xofigo must not be used with Zytiga and prednisone/prednisolone
EMA has recommended contraindicating the use of the prostate cancer medicine Xofigo (radium-223 dichloride) with Zytiga (abiraterone acetate) and prednisone/prednisolone, due to an increased risk of death and fractures with this combination.
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed the preliminary data from an ongoing clinical study in metastatic prostate cancer patients. In this study 34.7% of patients treated with Xofigo, Zytiga and prednisone/prednisolone have died so far, compared with 28.2% of patients given placebo, Zytiga and prednisone/prednisolone. Fractures have also occurred more frequently with the Xofigo combination than the placebo combination (26% versus 8.1%).
In view of the seriousness of the events reported, the PRAC has taken action by introducing a contraindication as a temporary measure to protect patients’ safety while an in-depth review of the benefits and risks of Xofigo is ongoing.
These are temporary measures until the ongoing in-depth review of the benefits and risks of Xofigo is complete. EMA will communicate further at the conclusion of the review.
The press release is available by clicking here and includes information to patients and healthcare professionals.
For more information on the European regulatory system for medicines, please click here (brochure available in all languages).
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With kind regards,
Public Engagement Department
Stakeholders and Communication Division