The European Pharmacovigilance Risk Assessment Committee (PRAC) announced today that it has started an investigation into an ongoing clinical trial involving prostate cancer patients who are taking the novel radiopharmaceutical radium-223 dichloride (Xofigo, Bayer).
The investigation was prompted by reports of an increase in deaths and fractures.
PRAC noted that this ongoing trial is comparing the radiopharmaceutical with placebo, both given in combination with abiraterone acetate (Zytiga, Janssen) and a steroid (prednisone or prednisolone).
This trial includes prostate cancer patients who have either no symptoms or mild symptoms, such as pain, the committee noted. The investigators are exploring an unapproved use of the radiopharmaceutical. At present, it is indicated for use in prostate cancer patients who have symptomatic bone metastases.
This trail that PRAC is investigating is the same trial that has just been unblinded on the recommendation of an independent data monitoring committee (IDMC), a move that the manufacturer of the radiopharmaceutical, Bayer, announced in press statement issued today.
“The IDMC recommendation is due to the observation of an imbalance of more fractures and deaths in the treatment arm investigating radium-223 in combination with abiraterone acetate and prednisone/prednisolone,” the company said.
“Patient safety is our top priority. We are therefore unblinding the study to thoroughly analyze the data,” said Mike Devoy, chief medical officer at Bayer.
“It is important to note that, based on available data from previous trials as well as real-world use, the benefit-risk profile of Xofigo in its approved indication remains favorable,” he added.
Radium-223 dichloride is currently approved for use in the treatment of castration-resistant prostate cancer (CRPC) in patients who have symptomatic bone metastases.
The unblinded trial, known as ERA223, was being conducted in chemotherapy-naive patients with asymptomatic or mildly symptomatic bone-predominant metastatic CRPC. It was investigating whether the addition of radium-223 dichloride to treatment with abiraterone acetate and prednisone/prednisolone would extend symptomatic skeletal event–free survival.
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