The US FDA has approved Xofigo (radium Ra 223 dichloride) for the treatment of symptomatic late-stage (metastatic) castration-resistant prostate cancer spread to bones but not to other organs in men.
The therapy is indicated for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.
Xofigo was approved three months ahead of schedule under priority review program.
The FDA Center for Drug Evaluation and Research office of hematology and oncology products director Richard Pazdur said, "Xofigo binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues."
A trial conducted in 809 men with symptomatic castration-resistant prostate cancer that spread to bones but not to other organs demonstrated the safety and effectiveness of Xofigo.
The most common side effects reported during trials in men receiving Xofigo were nausea, diarrhea, vomiting and swelling of the leg, ankle or foot.
The most common abnormalities detected during blood testing included low levels of red blood cells (anemia), lymphocytes (lymphocytopenia), white blood cells (leukopenia), platelets (thrombocytopenia) and infection-fighting white blood cells (neutropenia).
Bayer Pharmaceuticals is marketing Xofigo.
