Sub-group analysis of the clinical trial ERA 223 signal that the concerns about the use in combination of Zytiga and Xofigo might not cause a significant increase in the risk for developing bone fractures if a man is also simultaneously on a bone targeted therapy.
The European Medicines Agency (EMA) has recommended that the use of Xofigo (Radium-223) be restricted. The restrictions, because of safety and efficacy concerns in men with castrate resistant prostate cancer (mCRPC), include that Xofigo can be used only after two other treatments have been taken; when other therapies cannot be used and not in combination with other 2nd line hormone therapies.
There was a large meta-analysis recently published that compared the efficacy of abiraterone acetate (Zytiga), enzalutamide (Xtandi), cabazitaxel (Jevtana) and Radium-223 (Xofigo) in the treatment of castration-resistant, docetaxel-resistant metastatic prostate cancer.
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.
Early results from an international, open-label, phase 1/2 trial (NCT01934790) showed that it is possible to successfully re-treat men with the drug known as Xofigo (Ra-223). The study found that when used a second time, Xofigo was well tolerated and that it provides favorable effects on the cancer’s progression.
Bayer Healthcare has announced that it has halted and un-blinded its phase III clinical trial evaluating the combination of Radium 223 (Xofigo) and abiraterone (Zytiga).