Other safety alerts
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| European Union : PRAC issues warning about use of prostate cancer medicine Xofigo in combination with Zytiga and prednisone or prednisolone - Ongoing clinical trial shows an increased risk of death and fractures |
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The European Medicines Agency (EMA) is investigating an increased risk of death and fractures reported in an ongoing clinical trial with the prostate cancer medicine Xofigo (radium-223 dichloride).
The clinical trial is comparing Xofigo with placebo (a dummy treatment), both given in combination with Zytiga (abiraterone acetate) and prednisone/prednisolone. It includes prostate cancer patients with no symptoms or only mild symptoms, such as pain. Xofigo is currently authorised for use in patients whose prostate cancer has spread to the bones and is causing symptoms.
A preliminary analysis by an independent committee responsible for overseeing the trial reported a rate of death of 27% (109 out of 401 patients) for the Xofigo combination compared with 20% (82 out of 405 patients) for the placebo combination. Fractures also occurred more frequently with the Xofigo combination than the placebo combination (24% versus 7%).
Patients in this study are no longer treated with Xofigo and all the patients involved are being monitored closely. EMA will review the full results of this study as well as other available data to evaluate their impact on the authorised use of Xofigo.
While a full investigation is ongoing, doctors are asked not to use Xofigo in combination with Zytiga and prednisone/prednisolone to treat metastatic castration-resistant prostate cancer patients.
Patients who are currently being treated with Xofigo and have any questions about their treatment should contact their doctor.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../human_referral_prac_000071.jsp&mid=WC0b01ac05805c516f
In Hong Kong, Xofigo Solution for Injection 1100 KBq/ml (HK- 64332) and Zytiga Tablets 250mg (HK-61370) are pharmaceutial products registered by Bayer Healthcare Ltd. and Johnson and Johnson (Hong Kong) Ltd. respectively. Both products are prescription only medicines. So far, DH has received 9 cases of adverse drug reaction related to Xofigo and 2 cases of adverse drug reaction related to Zytiga, none of them are related to death and fractures.
The above clinical trial has not been conducted in Hong Kong. DH will keep vigilant against any safety updates of the drugs.
Ends/Saturday, December 2, 2017
Issued at HKT 13:00
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